The following drugs and medications are in some way related to, or used in the treatment of Opisthorchis viverrini, Liver Fluke. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Relieving symptoms of sinus congestion, pressure, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.
Nalex-A Liquid is an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, which relieves congestion and pressure.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Nalex-A Liquid. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Nalex-A Liquid. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Nalex-A Liquid may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Nalex-A Liquid as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Nalex-A Liquid.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; trouble sleeping; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Nalex-A side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.
Store Nalex-A Liquid at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nalex-A Liquid out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Nalex-A Liquid. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Carnitor 330 mg Tablets
Each tablet contains L-Carnitine inner salt 330 mg
For a full list of excipients, see section 6.1.
White, round, standard biconvex tablets, approximately 13 mm diameter.
Indicated for the treatment of primary and secondary carnitine deficiency in adults and children over 12 years of age.
For oral administration only.
Adults and children over 12 years of age
The tablets should be given in divided doses.
It is advisable to monitor therapy by measuring free and acyl carnitine levels in both plasma and urine.
The management of inborn errors of metabolism
The dosage required depends upon the specific inborn error of metabolism concerned and the severity of presentation at the time of treatment. However, the following can be considered as a general guide.
An oral dosage of up to 200mg/kg/day in divided doses (2 to 4) is recommended for chronic use in some disorders, with lower doses sufficing in other conditions. If clinical and biochemical symptoms do not improve, the dose may be increased on a short-term basis. Higher doses of up to 400mg/kg/day may be necessary in acute metabolic decompensation or the i.v. route may be required.
Haemodialysis - maintenance therapy
If significant clinical benefit has been gained by a first course of intravenous Carnitor then maintenance therapy can be considered using 1 g per day of Carnitor orally. On the day of the dialysis oral Carnitor has to be administered at the end of the session.
Hypersensitivity to any constituent of the product.
While improving glucose utilisation, the administration of L-carnitine to diabetic patients receiving either insulin or hypoglycaemic oral treatment may result in hypoglycaemia. Plasma glucose levels must be monitored regularly in order to adjust the hypoglycaemic treatment immediately, if required.
The safety and efficacy of oral L-carnitine has not been evaluated in patients with renal insufficiency. Chronic administration of high doses of oral L-carnitine in patients with severely compromised renal function or in end stage renal disease (ESRD) patients on dialysis may result in an accumulation of the potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-N-oxide (TMAO), since these metabolites are usually excreted in the urine. This situation has not been observed following intravenous administration of L-carnitine.
There are no known interactions.
Reproductive studies were performed in rats and rabbits. There was no evidence of a teratogenic effect in either species. In the rabbit but not in the rat there was a statistically insignificant greater number of post implantation losses at the highest dose tested (600mg/kg daily) as compared with control animals. The significance of these findings in man is unknown. There is no experience of use in pregnant patients with primary systemic carnitine deficiency. Taking into account the serious consequences in a pregnant woman who has primary systemic carnitine deficiency stopping treatment, the risk to the mother of discontinuing treatment seems greater than the theoretical risk to the foetus if treatment is continued.
Levocarnitine is a normal component of human milk. Use of levocarnitine supplementation in nursing mothers has not been studied.
None known.
Various mild gastro-intestinal complaints have been reported during the long term administration of oral levocarnitine, these include transient nausea and vomiting, abdominal cramps and diarrhoea.
Decreasing the dosage often diminishes or eliminates drug related patient body odour or gastro-intestinal symptoms when present. Tolerance should be monitored very closely during the first week of administration and after any dosage increase.
There have been no reports of toxicity from levocarnitine overdosage. Overdosage should be treated with supportive care.
ATC Code: A16AA01 (Amino acids and derivatives)
L-Carnitine is present as a natural constituent in animal tissues, micro-organisms and plants. In man the physiological metabolic requirements are met both by the consumption of food containing carnitine and the endogenous synthesis in the liver and kidneys from lysine with methionine serving as the methyl donor. Only the L-isomer is biologically active, playing an essential role in lipid metabolism as well as in the metabolism of ketone bodies as branched chain-amino-acids. L-Carnitine as a factor is necessary in the transport of long-chain fatty acids into the mitochondria - facilitating the oxidation of fatty acids rather than their incorporation into triglycerides. By releasing CoA from its thioesters, through the action of CoA; carnitine acetyl transferase, L-carnitine also enhances the metabolic flux in the Kreb's cycle; with the same mechanism it stimulates the activity of pyruvate dehydrogenase and in skeletal muscle, the oxidation of branched-chain amino acids. L-Carnitine is thus involved, directly or indirectly in several pathways so that its availability should be an important factor controlling not only the oxidative utilisation of fatty acids and ketone bodies but also that of glucose and some amino acids.
The absorbed L-carnitine is transported to various organ systems via the blood. The presence of membrane-bound proteins in several tissues including red blood cells that bind carnitine, suggest that a transport system in the blood and a cellular system for the collective uptake is present in several tissues. Tissue and serum carnitine concentration depend on several metabolic processes, carnitine bio-synthesis and dietary contributions, transport into and out of tissues, degradation and excretion may all affect tissue carnitine concentrations. Following administration, studies have demonstrated that a peak concentration of 71.89±5.13 μM was achieved 6 hours after dosing. The pharmacokinetic parameters showed an absorption phase half life of 1.45 hours and an elimination phase with a half-life of 3.34 hours. The apparent bioavailability was 14%.
The urinary recovery in 14 hours was 6.02% of the administered dose.
L-Carnitine is a naturally occurring body substance in human beings, plants and animals. Carnitor products are used to bring the level of L-carnitine in the body up to those found naturally. Appropriate pre-clinical studies have been undertaken and show no signs of toxicity at normal therapeutic levels.
Magnesium stearate (E572)
Polyvinylpyrrolidone
Microcrystalline cellulose (E460).
None known.
Unopened shelf life of 60 months (5 years).
Store below 25°C.
Blister packed in quantities of 30, 90, 100 and 180.
No special instructions.
Sigma-Tau Industrie Farmaceutiche Riunite SpA,
Viale Shakespeare 47-00144,
Rome, Italy.
PL 08381/0002
15 August 1990
15 October 2000
February 2009
Generic Name: clonidine (oral) (KLOE ni deen)
Brand Names: Catapres, Kapvay, Nexiclon XR
Clonidine lowers blood pressure by decreasing the levels of certain chemicals in your blood. This allows your blood vessels to relax and your heart to beat more slowly and easily.
Clonidine is used to treat hypertension (high blood pressure). The Kapvay brand of clonidine is used to treat attention deficit hyperactivity disorder (ADHD).
Clonidine may also be used for purposes not listed in this medication guide.
Before you take clonidine, tell your doctor if you have heart disease or severe coronary artery disease, a heart rhythm disorder, slow heartbeats, low blood pressure, a history of heart attack or stroke, kidney disease, or if you have ever had an allergic reaction to a clonidine transdermal skin patch (Catapres TTS).
Do not take two forms of clonidine at the same time.
If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.
Avoid becoming overheated or dehydrated during exercise and in hot weather.
To make sure you can safely take clonidine, tell your doctor if you have any of these other conditions:
heart disease or severe coronary artery disease;
heart rhythm disorder, slow heartbeats;
low blood pressure;
a history of heart attack or stroke;
if you have ever had an allergic reaction to a clonidine transdermal skin patch (Catapres TTS).
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.
Do not take two forms of clonidine at the same time.
Clonidine may be taken with or without food.
If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath) followed by low blood pressure (feeling light-headed, fainting), drowsiness, cold feeling, slow heart rate, shallow breathing, weakness, fainting, or pinpoint pupils.
Avoid becoming overheated or dehydrated during exercise and in hot weather.
fast or pounding heartbeats, tremors;
a very slow heart rate (fewer than 60 beats per minute);
feeling short of breath, even with mild exertion;
swelling, rapid weight gain;
confusion, hallucinations;
flu symptoms;
urination problems;
feeling like you might pass out.
Less serious side effects may include:
drowsiness, dizziness;
feeling tired or irritable;
cold symptoms such as runny or stuffy nose, sneezing, cough, sore throat;
mood changes;
sleep problems (insomnia), nightmares;
headache, ear pain;
mild fever;
feeling hot;
constipation, diarrhea, pain in your upper stomach;
dry mouth, increased thirst; or
loss of interest in sex, impotence, difficulty having an orgasm.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all other medications you use, especially:
clonidine transdermal skin patches (Catapres TTS);
digitalis (digoxin, Lanoxin, Lanoxicaps);
an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), doxepin (Sinequan), nortriptyline (Pamelor), and others;
a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;
heart or blood pressure medicine such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta), diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others; or
any other drugs to treat high blood pressure or heart problems.
This list is not complete and other drugs may interact with clonidine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: Nexiclon XR side effects (in more detail)
Nicorette Freshfruit 2mg Gum
Boots NicAssist Fruit Fresh 2 mg Gum
Chewing Gum containing 2mg nicotine, as nicotine resinate.
For excipients, see 6.1.
Medicated Chewing Gum
A square, coated, whitish piece of gum
Nicorette Freshfruit 2 mg Gum relieves and/or prevents craving and nicotine withdrawal symptoms associated with tobacco dependence. It is indicated to aid smokers wishing to quit or reduce prior to quitting, to assist smokers who are unwilling or unable to smoke, and as a safer alternative to smoking for smokers and those around them.
Nicorette Freshfruit 2 mg Gum is indicated in pregnant and lactating women making a quit attempt.
Adults and Children over 12 years of age
Nicorette Freshfruit 2 mg Gum should be chewed slowly according to the instructions.
The strength of gum to be used will depend on the smoking habits of the individual. In general, if the patient smokes 20 or less cigarettes a day, 2 mg nicotine gum is indicated. If more than 20 cigarettes per day are smoked, 4 mg nicotine gum will be needed to meet the withdrawal of the high serum nicotine levels from heavy smoking.
Nicorette Freshfruit 2 mg Gum should be used whenever the urge to smoke is felt or to prevent cravings in situations where these are likely to occur.
Smokers willing or able to stop smoking immediately should initially replace all their cigarettes with the Gum and as soon as they are able, reduce the number of gums used until they have stopped completely.
Smokers aiming to reduce cigarettes should use Nicorette Freshfruit 2 mg Gum, as needed, between smoking episodes to prolong smoke-free intervals and with the intention to reduce smoking as much as possible.
As soon as they are ready smokers should aim to quit smoking completely.
Maximum daily dose: 15 pieces per day.
When making a quit attempt behavioural therapy, advice and support will normally improve the success rate. Those who have quit smoking, but are having difficulty discontinuing Nicorette Freshfruit 2 mg Gum are recommended to contact their pharmacist or doctor for advice.
For those using the 4 mg gum, switching to the 2 mg gum may be helpful when stopping treatment or reducing the number of gums used each day.
The chewing gums should be used whenever there is an urge to smoke according to the “chew and rest” technique described on the pack. After about 30 minutes of such use, the gum will be exhausted. Absorption of nicotine is through the buccal mucosa, any nicotine which is swallowed being destroyed by the liver.
Hypersensitivity to nicotine or any component of the chewing gum.
Nicorette Freshfruit 2 mg Gum is contraindicated in children under the age of 12 years.
Any risks that may be associated with NRT are substantially outweighed by the well established dangers of continued smoking.
Underlying cardiovascular disease: In stable cardiovascular disease Nicorette Freshfruit 2mg Gum presents a lesser hazard than continuing to smoke. However dependent smokers currently hospitalised as a result of myocardial infarction, severe dysrhythmia or CVA and who are considered to be haemodynamically unstable should be encouraged to stop smoking with non-pharmacological interventions. If this fails, Nicorette Freshfruit 2mg Gum may be considered, but as data on safety in this patient group are limited, initiation should only be under medical supervision.
Diabetes mellitus: Patients with diabetes mellitus should be advised to monitor their blood sugar levels more closely than usual when NRT is initiated as catecholamines released by nicotine can affect carbohydrate metabolism.
GI disease: Swallowed nicotine may exacerbate symptoms in patients suffering from oesophagitis, gastritis or peptic ulcers and oral NRT preparations should be used with caution in these conditions. Ulcerative stomatitis has been reported.
Renal or hepatic impairment: Nicorette Freshfruit 2mg Gum should be used with caution in patients with moderate to severe hepatic impairment and/or severe renal impairment as the clearance of nicotine or its metabolites may be decreased with the potential for increased adverse effects.
Danger in small children: Doses of nicotine tolerated by adult and adolescent smokers can produce severe toxicity in small children that may be fatal. Products containing nicotine should not be left where they may be misused, handled or ingested by children. Nicotine gum should be disposed of with care.
Phaeochromocytoma and uncontrolled hyperthyroidism: As nicotine causes release of catecholamines, Nicorette Freshfruit 2mg Gum should be used with caution in patients with uncontrolled hyperthyroidism or phaeochromocytoma.
Transferred dependence: Transferred dependence is rare and is both less harmful and easier to break than smoking dependence.
Stopping smoking: Polycyclic aromatic hydrocarbons in tobacco smoke induce the metabolism of drugs metabolised by CYP 1A2 (and possibly by CYP 1A1). When a smoker stops smoking, this may result in slower metabolism and a consequent rise in blood levels of such drugs. This is of potential clinical importance for products with a narrow therapeutic window, e.g. theophylline, clozapine and ropinirole.
Excipients: Nicorette Freshfruit 2mg Gum also contains butylated hydroxy toluene (E321); this may cause irritation to the mucous membranes.
Denture warning: Smokers who wear dentures may experience difficulty in chewing Nicorette Freshfruit 2mg Gum. The chewing gum may stick to, and may in rare cases damage dentures.
No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established. However nicotine may possibly enhance the haemodynamic effects of adenosine i.e. increase in blood pressure and heart rate and also increase pain response (angina-pectoris type chest pain) provoked by adenosine administration.
Pregnancy
Stopping smoking is the single most effective intervention for improving the health of both the pregnant smoker and her baby, and the earlier abstinence is achieved the better. Ideally smoking cessation during pregnancy should be achieved without NRT. However, if the mother cannot (or is considered unlikely to) quit without pharmacological support, NRT may be used as the risk to the fetus is lower than that expected with smoking tobacco. Stopping completely is by far the best option but if this is not achievable Nicorette Freshfruit 2 mg Gum may be used in pregnancy as a safer alternative to smoking. Because of the potential for nicotine-free periods, intermittent dose forms are preferable, but patches may be necessary if there is significant nausea and/or vomiting. If patches are used they should, if possible, be removed at night when the fetus would not normally be exposed to nicotine.
Lactation
The relatively small amounts of nicotine found in breast milk during NRT use are less hazardous to the infant than second-hand smoke. Intermittent dose forms would minimize the amount of nicotine in breast milk and permit feeding when levels were at their lowest.
Not applicable.
Some symptoms may be related to nicotine withdrawal associated with stopping smoking. These can include; irritability/aggression, dysphoria/depressed mood, anxiety, restlessness, poor concentration, increased appetite/weight gain, urges to smoke (cravings), night-time awakenings/sleep disturbance and decreased heart rate.
Increased frequency of aphthous ulcer may occur after abstinence from smoking. The causality is unclear.
Nicorette Freshfruit 2mg Gum may cause adverse reactions similar to those associated with nicotine given by other means, including smoking, and these are mainly dose-dependent. At recommended doses Nicorette Freshfruit 2mg Gum has not been found to cause any serious adverse effects. Most of the undesirable effects reported by the patients occur during the first 3-4 weeks after start of treatment.
Excessive consumption of Nicorette Freshfruit 2mg Gum by those who have not been in the habit of inhaling tobacco smoke could possibly lead to nausea, faintness or headaches. Excessive swallowing of dissolved nicotine may, at first, cause hiccupping.
Nicotine from the gum may sometimes cause a slight irritation of the throat at the start of treatment and may also cause increased salivation.
Those who are prone to indigestion may suffer initially from minor degrees of indigestion or heartburn if the 4mg nicotine gum is used; slower chewing and the use of the 2mg nicotine gum (if necessary more frequently) will usually overcome this problem.
The chewing gum may stick to, and may in rare cases damage dentures.
Reported adverse events associated with Nicorette 2mg and 4mg gum include:
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* Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1 000, <1/100); rare (>1/10 000, <1/1 000); very rare (<1/10 000), including isolated reports.
Symptoms: The minimum lethal dose of nicotine in a non-tolerant man has been estimated to be 40 to 60mg. Symptoms of acute nicotine poisoning include nausea, salivation, abdominal pain, diarrhoea, sweating, headache, dizziness, disturbed hearing and marked weakness. In extreme cases, these symptoms may be followed by hypotension, rapid or weak or irregular pulse, breathing difficulties, prostration, circulatory collapse and terminal convulsions.
Management of an overdose: All nicotine intake should stop immediately and the patient should be treated symptomatically. Artificial respiration should be instituted if necessary. Activated charcoal reduces the gastro-intestinal absorption of nicotine.
Pharmacotherapeutic group: Drugs used in nicotine dependence
ATC code: N07B A01
The pharmacological effects of nicotine are well documented. Those resulting from chewing Nicorette Freshfruit 2 mg Gum are comparatively small. The response at any one time represents a summation of stimulant and depressant actions from direct, reflex and chemical mediator influences on several organs. The main pharmacological actions are central stimulation and/or depression; transient hyperpnoea; peripheral vasoconstriction (usually associated with a rise in systolic pressure); suppression of appetite and stimulation of peristalsis.
Increased appetite is a recognised symptom of nicotine withdrawal and post-cessation weight gain is common. Clinical trials have demonstrated that Nicotine Replacement Therapy can help control weight following a quit attempt.
Nicotine administered in chewing gums is readily absorbed from the buccal mucous membranes. Demonstrable blood levels are obtained within 5 – 7 minutes and reach a maximum about 30 minutes after the start of chewing. Blood levels are roughly proportional to the amount of nicotine chewed and have been shown never to exceed those obtained from smoking cigarettes.
Preclinical data indicate that nicotine is neither mutagenic nor genotoxic.
There are no other findings derived from preclinical testing of relevance to the prescriber in determining the safety of the product which have not been considered in other relevant sections of this Summary of Product Characteristics.
Core Gum
Chewing gum base, containing butylated hydroxy toluene (E321)
Xylitol
Peppermint oil
Sodium carbonate, anhydrous
Sodium hydrogen carbonate
Acesulfame Potassium
Levomenthol
Magnesium oxide, light
Talc
Sub-coating
Tuttifrutti QL84441
Hypromellose
Sucralose
Polysorbate 80
Purified water
Coating
Xylitol
Acacia
Titanium dioxide (E171)
Tuttifrutti Ql84441
Carnauba wax
Purified water
Not applicable.
3 Years
Do not store above 25°C.
PVC/PVDC/Al Blister packed strips each containing 15 pieces supplied in packs of 15, 30, 105 and 210 pieces.
Blister packed strips each containing 6 pieces supplied in packs of 12 pieces.
Blister packed strips each containing 10 pieces supplied in packs of 10 pieces.
Not all pack sizes may be marketed.
Dispose of Nicorette Gum sensibly.
Any unused product or waste material should be disposed of in accordance with local requirements.
McNeil Products Limited
Foundation Park
Roxborough Way
Maidenhead
Berkshire SL6 3UG
United Kingdom
PL 15513/0136
18/07/2006
27 September 2011
Generic Name: nitroglycerin (Transdermal route)
nye-troe-GLIS-er-in
In the U.S.
In Canada
Available Dosage Forms:
Therapeutic Class: Antianginal
Chemical Class: Nitrate
Nitroglycerin transdermal is used to prevent angina (chest pain) caused by coronary artery disease. It does not work fast enough to relieve the pain of an angina attack that has already started.
Nitroglycerin transdermal belongs to the group of medicines called nitrates. It works by relaxing the blood vessels and increasing the supply of blood and oxygen to the heart while reducing its work load. When used regularly on a long-term basis, this helps prevent angina attacks from occurring.
This medicine is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of nitroglycerin transdermal in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nitroglycerin transdermal in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving nitroglycerin transdermal.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain nitroglycerin. It may not be specific to Nitrodur 0.4. Please read with care.
Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. It will only work if applied correctly.
This form of nitrate is used to reduce the number of angina attacks over a long time. It will not relieve an attack that has already started because it works too slowly. The ointment and patch forms release medicine gradually to provide an effect for 7 to 10 hours. Check with your doctor if you also need a fast-acting medicine to relieve the pain of an angina attack.
You should use this medicine first thing in the morning and follow the same schedule each day. This medicine works best if you have a "drug-free" period of time every day when you do not use it. Your doctor will schedule your doses during the day to allow for a drug-free time. Follow the schedule of dosing carefully so the medicine will work properly.
This medicine comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.
For patients using the ointment:
For patients using the patch system:
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
After removing a used patch, fold it in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.
If you will be taking this medicine for a long time, it is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not take sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) while you are using this medicine. Using these medicines together may cause blurred vision, dizziness, lightheadedness, or fainting. If you are taking these medicines and you experience an angina attack, you must go to the hospital right away.
This medicine may cause headaches. These headaches are a sign that the medicine is working. Do not stop using the medicine or change the time you use it in order to avoid the headaches. If you have severe pain, talk with your doctor.
Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help.
Dizziness, lightheadedness, or fainting is also more likely to occur if you drink alcohol, stand for long periods of time, exercise, or if the weather is hot. While you are taking this medicine, be careful to limit the amount of alcohol you drink. Also, use extra care during exercise or hot weather or if you must stand for long periods of time.
Do not stop using this medicine without checking with your doctor first. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.
Tell the doctor in charge that you are using this medicine before having a magnetic resonance imaging (MRI) scan. Skin burns may occur at the site where the patch is worn during this procedure. Ask your doctor if the patch should be removed before having an MRI scan. You might need to put on a new patch after the procedure.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Nitrodur 0.4 side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
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Covonia Vapour Drops
Covonia Vapour Drops contains the following active ingredients:
Menthol BP natural or Menthol BP synthetic 17.5% w/v
Peppermint Oil BP 0.2% v/v
For excipients, see 6.1
Inhalation vapour, solution.
A clear yellow liquid.
For the symptomatic relief of catarrh, hay fever and nasal congestion.
Adults, the elderly and children over 3 months:
Sprinkle a few drops on a handkerchief and inhale the vapour.
Children under 3 months:
Not recommended for children under 3 months.
Hypersensitivity to any of the ingredients.
Not recommended for children under 3 months.
In young children, menthol can cause spasm of the glottis and cases of collapse have been reported in children following local application.
The label states:
1 If symptoms persist, consult your doctor.
2 Avoid contact with the eyes.
3 Not to be taken internally.
4 Keep all medicines out of the sight and reach of children.
None stated.
The safety of Covonia Vapour Drops in pregnancy and lactation has not been established, but is not thought to constitute a hazard.
No or negligible influence.
Occasional hypersensitivity reactions are a possibility.
Following oral ingestion, the following symptoms may be expected: insomnia, unsteady gait, tremor of hands, nausea and vomiting, delirium, epileptiform convulsions, depression and coma. Treatment should consist of gastric lavage and aspiration. A saline purgative such as 30g of sodium sulphate in 250ml of water may be given and any convulsions controlled by intravenous diazepam.
R01A X – Other nasal preparations, combinations
Menthol, a frequent constituent of inhalation preparations, produces a sensation of decreased nasal congestion, possibly by virtue of its local anaesthetic action on the nasal mucosal surface. Peppermint Oil possesses the physiological actions and therapeutic uses of menthol.
Not applicable.
No data of relevance to the prescriber, which is additional to that included in other sections of the SPC.
Eucalyptus Oil Ph. Eur
Cajuput Oil BPC 1973
Spike Lavender Fragrance Oil HSE
Industrial Methylated Spirit BP
None stated.
10ml: 36 months
15ml: 36 months
30ml: 36 months
Do not store above 25°C
10ml, 15ml & 30ml pack - amber glass bottle with polyethylene screw cap with integral polyethylene dropper.
Not applicable.
Thornton & Ross Limited
Linthwaite
Huddersfield
West Yorkshire
HD7 5QH
United Kingdom
PL 00240/0073
19 June 2002
19/09/03
Not Applicable
Not Applicable
Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)
Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN
There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.
Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.
Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.
Prenatal vitamins may also be used for purposes not listed in this medication guide.
There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.
Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.
Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.
Before taking prenatal vitamins, tell your doctor about all of your medical conditions.
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.
Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.
The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.
Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.
Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.
When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:
upset stomach;
headache; or
unusual or unpleasant taste in your mouth.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:
diuretics (water pills);
heart or blood pressure medications;
tretinoin (Vesanoid);
isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);
trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or
an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.
This list is not complete and other drugs may interact with prenatal vitamins. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Generic Name: Factor VIIa (Recombinant)
Class: Hemostatics
VA Class: BL500
Risk of serious arterial and venous thromboembolic adverse events, particularly when factor VIIa (recombinant) is used outside FDA-labeled indications.1 29 36 37 39 (See Thromboembolic Events under Cautions.)
Both fatal and nonfatal thromboembolic events have been reported in clinical studies and during postmarketing experience.1 19 35 36 38
Discuss risk of thromboembolism with patient.1 Monitor for signs and symptoms of coagulation system activation and thrombosis during therapy.1
Biosynthetic preparation (recombinant DNA origin) of blood coagulation factor VIIa.1
Treatment and prevention of hemorrhagic episodes in patients with hemophilia A (antihemophilic factor [factor VIII] deficiency; classic hemophilia) or hemophilia B (factor IX deficiency; Christmas disease) who have developed inhibitors (alloantibodies) to factor VIII or factor IX, respectively;1 11 21 22 25 26 designated an orphan drug by FDA for this use.2
Prevention of bleeding in patients with hemophilia A or B with inhibitors to factor VIII or factor IX, respectively, undergoing surgery or invasive procedures;1 21 22 25 26 designated an orphan drug by FDA for this use.2
Management of hemophilia in patients with inhibitors may be difficult and consultation with a hemophilia treatment center is strongly recommended.11 21
The Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation and other experts state that factor VIIa (recombinant) is one of several therapeutic options for the management of hemophilic patients with inhibitors.6 11 21 Treatment of choice depends on several factors (e.g., severity and location of bleeding, type [low- or high-responding] and titer of inhibitor, history of anamnestic response, previous response to these preparations).5 6 11 21
Patients with low titers (e.g., <5–10 Bethesda units/mL) of inhibitors may be effectively treated with high dosages of coagulation factor concentrates (factor VIII or factor IX).21 23 33 34 48 49 Bypassing agents (e.g., factor VIIa [recombinant]) generally are used when a response to specific factor replacement therapy has not been obtained or is unlikely.21 23 MASAC recommends use of a bypassing agent in hemophilia A or hemophilia B patients with inhibitors in settings where clotting factor preparations would otherwise be used, including before and after surgery and physical therapy.22
Treatment and prevention of bleeding in patients with acquired hemophilia (i.e., those with acquired inhibitor antibodies [autoantibodies] to factor VIII);1 20 26 designated an orphan drug by FDA for this use.2
Prevention of bleeding in patients with acquired hemophilia undergoing surgery or invasive procedures;1 20 21 25 26 designated an orphan drug by FDA for this use.2
One of several options used to control bleeding in patients with acquired hemophilia.20
Management of hemorrhagic episodes in patients with congenital factor VII deficiency; 1 11 12 16 24 26 designated an orphan drug by FDA for this use.2
Prevention of bleeding in patients with congenital factor VII deficiency undergoing surgery or invasive procedures;1 designated an orphan drug by FDA for this use.2
MASAC recommends use of factor VIIa (recombinant) for management of bleeding in patients with congenital factor VII deficiency.11
Has been used in nonhemophilic patients† in a variety of clinical settings (e.g., intracranial hemorrhage [ICH], advanced liver disease, liver surgery, trauma, cardiac surgery, spinal surgery, GI bleeding, reversal of warfarin anticoagulation) to control or prevent excessive or life-threatening hemorrhage.1 19 25 26 35 36 38 39 41 42 43 44 45 However, efficacy and safety of the drug in these settings not established.1 36 42 43 45 Additional randomized controlled studies are needed to establish the role of factor VIIa (recombinant) as a general hemostatic agent in patients without hemophilia.26 27 36 40 41 42
Administer only under direct supervision of a clinician experienced in the management of bleeding disorders.1
Adjust dose and dosing interval based on severity of bleeding and hemostatic response.1
Coagulation parameters (e.g., PT/INR, aPTT, plasma factor VII clotting activity [FVII:C]) have not been shown to directly correlate with hemostatic response.1 20 25 26 27 31 42 (See Adequate Patient Evaluation and Monitoring under Cautions.)
Administer by slow (over 2–5 minutes) IV injection.1
Has been given as a continuous IV infusion†;7 8 9 10 25 26 28 42 however, manufacturer states that the drug should not be admixed with any IV infusion solutions.1 13 If flushing of the line is necessary prior to and following drug administration, use 0.9% sodium chloride injection.1
Select appropriate vial size and diluent based on indicated dosage.1 Prior to reconstitution, allow lyophilized powder and diluent supplied by manufacturer (histidine diluent) to warm to room temperature (≤37°C).1
Reconstitute vials containing 1, 2, or 5 mg of lyophilized factor VIIa (recombinant) with 1.1, 2.1, or 5.2 mL of histidine diluent, respectively, to provide a solution containing approximately 1 mg/mL (1000 mcg/mL).1 Reconstitute only with the histidine diluent provided by manufacturer; do not use sterile water for injection or any other diluent.1
Direct diluent toward side of vial; do not inject directly onto powder.1
Gently swirl solution until all the powder is dissolved.1
May store reconstituted solutions under refrigeration or at room temperature, but administer within 3 hours after reconstitution; discard any unused solution after 3 hours.1
90 mcg/kg every 2 hours until hemostasis achieved or response to drug is inadequate; doses of 35–120 mcg/kg have been used successfully in clinical studies.1 4 5
For severe bleeding episodes, continue treatment every 3–6 hours after hemostasis is achieved to prevent recurrence of bleeding.1 Optimum duration of therapy not established; minimize duration of posthemostatic dosing.1 (See Posthemostatic Dosing under Cautions.)
Minor surgery: 90 mcg/kg immediately prior to procedure; repeat every 2 hours during procedure.1 Continue every 2 hours postoperatively for 48 hours, then every 2–6 hours until healing achieved.1
Major surgery: 90 mcg/kg immediately prior to procedure; repeat every 2 hours during procedure.1 Continue every 2 hours postoperatively for 5 days, then every 4 hours until healing achieved.1 Administer additional doses, if required.1
70–90 mcg/kg every 2–3 hours until hemostasis achieved.1
15–30 mcg/kg every 4–6 hours until hemostasis achieved.1 Although minimum effective dose not established, manufacturer states that doses as low as 10 mcg/kg have been effective.1
Individualize dose and dosing frequency.1 Monitor PT and plasma factor VII clotting activity (FVII:C) prior to and following administration.1 Consider possibility that antibodies to factor VII may have developed if therapeutic response or expected factor VII levels are not achieved with calculated dosages.1 (See Development of Antibodies to Factor VII under Cautions.)
90 mcg/kg every 2 hours until hemostasis achieved or response to drug is inadequate; doses of 35–120 mcg/kg have been used successfully in clinical studies.1 4 5
For severe bleeding episodes, continue treatment every 3–6 hours after hemostasis is achieved to prevent recurrence of bleeding.1 Optimum duration of therapy not established; minimize duration of posthemostatic dosing.1 (See Posthemostatic Dosing under Cautions.)
Minor surgery: 90 mcg/kg immediately prior to procedure; repeat every 2 hours during procedure.1 Continue every 2 hours for 48 hours postoperatively, then every 2–6 hours until healing achieved.1
Major surgery: 90 mcg/kg immediately prior to procedure; repeat every 2 hours during procedure.1 Continue every 2 hours postoperatively for 5 days, then every 4 hours until healing achieved.1 Administer additional doses, if required.1
70–90 mcg/kg every 2–3 hours until hemostasis achieved.1
15–30 mcg/kg every 4–6 hours until hemostasis achieved. Although minimum effective dose not established, manufacturer states that doses as low as 10 mcg/kg have been effective.1
Individualize dose and dosing frequency.1 Consider possibility that antibodies to factor VII may have developed if therapeutic response or expected factor VII levels are not achieved with calculated dosages.1 (See Development of Antibodies to Factor VII under Cautions.)
Manufacturer states no known contraindications.1
Risk of serious thromboembolic events.1 17 19 20 23 25 26 27 29 35 36 Adverse arterial and venous thromboembolic events reported in clinical studies and during postmarketing experience.1 17 19 20 23 25 26 27 29 35 36 Risk of thrombosis, particularly arterial thromboembolic events (e.g., myocardial ischemia, MI, cerebral ischemia and/or infarction), may be further increased in nonhemophilic patients who receive factor VIIa (recombinant) for non-FDA-labeled indications.19 35 36 37 38
Potentially greater risk in patients with disseminated intravascular coagulation (DIC), advanced atherosclerotic disease, crush injuries, septicemia, or concomitant treatment with activated or nonactivated prothrombin complex concentrates (APCCs or PCCs) due to circulating tissue factor (TF) or predisposing coagulopathy.1 17 19
Weigh risk of thromboembolism against benefits of factor VIIa (recombinant) therapy.35 Use with caution, especially in patients with known risk factors for thromboembolism (e.g., elderly patients, neonates, those with a history of CHD, liver disease, DIC, or who require postoperative immobilization).1 19 20 25 27 29
Closely monitor for thrombosis or other signs of an activated coagulation system.1 25 27 39 Reduce dosage or discontinue therapy if thrombosis occurs or laboratory tests confirm presence of intravascular coagulation.1
Report thrombotic complications and other adverse effects associated with factor VIIa (recombinant) to the Hemophilia and Thrombosis Research Society (HTRS) Registry at 877-362-7355.1 13 36
Safety and efficacy of prolonged elevations of factor VIIa have not been evaluated, and most appropriate duration of posthemostatic therapy with factor VIIa (recombinant) is not known; exercise caution if factor VIIa (recombinant) used for extended periods to maintain hemostasis.1 Minimize duration of posthemostatic therapy and closely monitor patients (preferably by a clinician experienced in the posthemostatic management of hemophilia).1
Development of antibodies to factor VII reported rarely in patients with congenital factor VII deficiency receiving factor VIIa (recombinant).1 12 25 In some cases, inhibitory effects were demonstrated in vitro;1 clinical importance not established.12
Monitor PT and factor VII coagulant activity prior to and following drug administration in patients with factor VII deficiency.1 Suspect antibody formation if factor VIIa activity fails to reach the expected level, PT is not corrected, or bleeding is not controlled after treatment with recommended dosages of factor VIIa (recombinant) and perform appropriate screening tests.1 (See Adequate Patient Evaluation and Monitoring under Cautions.)
Monitor patients with congenital factor VII deficiency receiving factor VIIa (recombinant) for evidence of antibody development.1 (See Development of Antibodies to Factor VII under Cautions.)
Evaluate hemostasis to determine effectiveness of factor VIIa (recombinant) and need for dosage adjustments.1 Laboratory parameters (e.g., PT/INR, aPTT, plasma factor VII clotting activity) have not been shown to correlate directly with hemostasis; furthermore, coagulation assays may produce different results depending on the specific reagent used.1 25 26 27 31 42
Administration of factor VIIa (recombinant) generally shortens PT and aPTT and has been shown to rapidly normalize INR; however, clinical importance not known.1 20 25 31 42 43 44
Hypersensitivity reactions (e.g., including anaphylactic shock, flushing, urticaria, rash, angioedema) reported.1 17 Administer with caution in patients with known hypersensitivity to factor VIIa (recombinant) or any ingredient in the formulation.1
Factor VIIa (recombinant) contains trace amounts of animal protein which may stimulate antibody production and cause hypersensitivity reactions.1 13 Use with caution in patients with known hypersensitivity to murine, hamster, or bovine proteins.1
If severe hypersensitivity or anaphylaxis occurs, discontinue drug immediately and initiate appropriate therapy.13
Category C.1
Thrombotic events have been reported in women without a bleeding disorder receiving factor VIIa (recombinant) for uncontrolled postpartum hemorrhage.1 (See Thromboembolic Events under Cautions.)
Not known whether factor VIIa (recombinant) is distributed into human milk.1 Discontinue nursing or the drug.1
NovoSeven RT has not been evaluated in patients ≤16 years of age to determine if there are differences in safety and efficacy among various pediatric age groups.1 13 The predecessor product (NovoSeven) has been used in pediatric patients 0–16 years of age; no substantial differences in safety and efficacy relative to adults.1 7 13
In clinical trials, dosing in pediatric patients was determined according to body weight and not age.1
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.1 Potential risk of adverse thromboembolic events in geriatric patients; use with caution.1 17 19 26 (See Thromboembolic Events under Cautions.)
Fever,1 hemorrhage,1 injection site reaction,1 arthralgia,1 headache,1 BP changes (hypotension or hypertension),1 nausea,1 vomiting,1 pain,1 edema,1 rash.1
Drug | Interaction | Comments |
|---|---|---|
Antifibrinolytic agents (e.g., aminocaproic acid, tranexamic acid) | No specific interaction reported with concomitant use21 | May be used concomitantly to enhance hemostasis21 |
Anti-inhibitor coagulant complex (Activated Prothrombin Complex Concentrate; APCC) | Potential additive thrombotic effects1 | Avoid concomitant use1 |
Factor IX Complex (Prothrombin Complex Concentrate; PCC) | Potential additive thrombotic effects1 | Avoid concomitant use1 |
Circulating factor VIIa concentrations increase approximately 1000-fold following administration of factor VIIa (recombinant).25 26
Mean maximum factor VII activity observed approximately 10 minutes following single IV infusion in one study.30
Factor VII activity decreases rapidly and returns to baseline within 24 hours following IV infusion.30
Distributes into a volume 2–3 times that of plasma.31
Not known whether distributed into human milk.1
2.3 hours (range: 1.7–2.7 hours) in patients with hemophilia A or B and 2.8–3.1 hours in patients with congenital factor VII deficiency.1
Clearance in children is increased compared with adolescents and adults.25 28
Half-life in children is shorter than that observed in adolescents and adults.25 28
2–25°C; do not freeze.1 Protect from light.1 13 Do not use beyond expiration date.1
Store reconstituted solutions of the drug at room temperature or under refrigeration; do not freeze or store in syringes.1 13 Use solution within 3 hours of reconstitution.1
For information on systemic interactions resulting from concomitant use, see Interactions.
Do not mix with other infusion solutions.1
Factor VIIa (recombinant), a hemostatic agent, is structurally nearly identical to human plasma-derived coagulation factor VIIa.1 29
Promotes hemostasis through activation of the extrinsic blood coagulation pathway.1
Following injury to vessel wall, tissue factor (TF) is exposed to circulating blood; TF-FVIIa complexes are formed on TF-bearing cells, where they activate factor X to factor Xa and factor IX to factor IXa.1 25 26 29
Factor Xa, in complex with factor V, calcium, and phospholipids, converts prothrombin to thrombin and subsequently activates fibrinogen to fibrin to form a hemostatic plug that provides local hemostasis.1 29 This process also may occur on the surface of activated platelets.1 26 29
Produces hemostasis in the absence of factor VIII or factor IX by binding to activated platelets and directly activating factor X to generate thrombin independently of TF.1 11 22 25 26 27 29
Produces circulating concentrations of factor VIIa that are approximately 1000-fold higher than physiologic levels.25 26 32
Importance of understanding risks and benefits associated with therapy.1
Importance of discontinuing therapy and immediately informing clinician if hives, urticaria, chest tightness, hypotension, wheezing, or anaphylaxis occurs.1
Importance of warning patients about the possibility of thromboembolism and advising them to monitor for signs of thrombosis, including new-onset swelling and pain in the limbs or abdomen, new-onset chest pain, shortness of breath, loss of sensation or motor skills, or altered consciousness or speech.1 Advise patients to immediately seek medical attention if any manifestations of thromboembolism occur.1
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., diabetes, cancer, cardiovascular disease, thromboembolic disease, liver disease).1 25
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | For injection, for IV use only | 1 mg | NovoSeven RT | Novo Nordisk |
2 mg | NovoSeven RT | Novo Nordisk | ||
5 mg | NovoSeven RT | Novo Nordisk |
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
1. Novo Nordisk. NovoSeven RT (coagulation factor VIIa [recombinant] room temperature stable) prescribing information. Princeton, NJ; 2010 15 Jan.
2. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; 2001 June. From FDA web site ()
3. Arkin S, Blei F, Fetten J et al. Human coagulation factor FVIIa (recombinant) in the management of limb-threatening bleeds unresponsive to alternative therapies: results from the NovoSeven emergency-use programme in patients with severe haemophilia or with acquired inhibitors. Blood Coag Fibrino. 2000; 11:255-9.
4. Shirahata A, Kamiya T, Takamatsu J et al. Clinical trial to investigate the pharmacokinetics, pharmacodynamics, safety, and efficacy of recombinant factor VIIa in Japanese patients with hemophilia with inhibitors. Int J Hematol. 2001; 73:517-25. [PubMed 11503968]
5. Ingerslev J. Efficacy and safety of recombinant factor VIIa in the prophylaxis of bleeding in various surgical procedures in hemophilic patients with factor VIII and factor IX inhibitors. Semin Thromb Hemost. 2000; 26:425-32. [PubMed 11092219]
6. Kulkarni R, Aledort LM, Berntorp E et al. Therapeutic choices for patients with hemophilia and high-titer inhibitors. Am J Hematol. 2001; 67:240-6. [PubMed 11443636]
7. Shapiro AD. Recombinant factor VIIa in the treatment of bleeding in hemophilic children with inhibitors. Semin Thromb Hemost. 2000; 26:413-9. [PubMed 11092217]
8. Schulman S for the rFVIIa-CI Group. Continuous infusion of recombinant factor VIIa in hemophilic patients with inhibitors: safety, monitoring, and cost effectiveness. Semin Thromb Hemost. 2000; 26:421-4. [PubMed 11092218]
9. Chuansumrit A, Isarangkura P, Angchaisuksiri P et al. Controlling acute bleeding episodes with recombinant factor VIIa in haemophiliacs with inhibitor: continuous infusion and bolus injection. Haemophilia. 2000; 6:61-5. [PubMed 10781189]
10. Baudo F, Redaelli R, Caimi TM et al. The continuous infusion of recombinant activated factor VIIa (rFVIIa) in patients with factor VIII inhibitors activates the coagulation and fibrinolytic systems without clinical complications. Thromb Res. 2000; 99:21-4. [PubMed 10904100]
11. Medical and Scientific Advisory Council (MASAC), National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders (revised April 2010). MASAC recommendation #195. From National Hemophilia Foundation website ().Accessed 17 August 2010.
12. Hunault M, Bauer KA. Recombinant factor VIIa for the treatment of congenital factor VII deficiency. Semin Thromb Hemost. 2000; 26:401-5. [PubMed 11092215]
13. Novo Nordisk Pharmaceuticals, Inc., Princeton, NJ: Personal communication.
14. Shapiro AD, Gilchrist GS, Hoots WK et. al. Prospective, randomized trial of two doses of rFVIIa (NovoSeven) in haemophilia patients with inhibitors of undergoing surgery. Thromb Haemost. 1998; 80:773-8. [PubMed 9843170]
15. Key NS, Aledort LM, Beardsley D, et al. Home treatment of mild to moderate bleeding episodes using recombinant factor VIIa (NovoSeven) in haemophiliacs with inhibitors. Thromb Haemost. 1998;80:912-8.
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