Lemsip Cough Dry
1. Name Of The Medicinal Product
Lemsip Cough Dry2. Qualitative And Quantitative Composition
Citric acid monohydrate
Lemon oil terpeneless
BP3. Pharmaceutical Form
Linctus.4. Clinical Particulars 4.1 Therapeutic Indications
For the symptomatic relief of dry tickly coughs and sore throats.4.2 Posology And Method Of Administration
Route of administration - oral.
Adults and children over 12: Two 5ml spoonfuls, three or four times daily.
Children 1-12 years: One 5ml spoonful, three or four times daily.
No special dose is required for elderly patients.4.3 Contraindications
Hypersensitivity to the active substance or any of the excipients.
Do not give to children under 1 year.4.4 Special Warnings And Precautions For Use
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per 5 ml.
Contains esters of parahydroxybenzoic acid which may cause allergic reactions (possibly delayed).4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known.4.6 Pregnancy And Lactation
As with many other medicines, this product should be avoided in the first three months of pregnancy and during lactation unless the benefits outweigh any risks; no significant problems have been reported in breast-fed infants from mothers taking this product.4.7 Effects On Ability To Drive And Use Machines
None known.4.8 Undesirable Effects
None known.4.9 Overdose
Overdosage is unlikely but if it does occur then treatment consists of general supportive therapy and may include gastric lavage.5. Pharmacological Properties 5.1 Pharmacodynamic Properties
Glycerol, honey and syrup act as demulcents and provide a soothing medium for an irritated throat.
The citric acid monohydrate and the lemon oil, terpeneless both add to the sharpness of the product and enhance the flavour.5.2 Pharmacokinetic Properties
Not applicable.5.3 Preclinical Safety Data
No preclinical findings of relevance have been reported.6. Pharmaceutical Particulars 6.1 List Of Excipients
Ethanol (96%), Nipasept sodium and water.6.2 Incompatibilities
None known.6.3 Shelf Life
Three years.6.4 Special Precautions For Storage
Store below 25°C.6.5 Nature And Contents Of Container
Amber glass bottles with a polypropylene cap with a polyethylene tamper-evident band with expanded polyethylene wad. Pack sizes: 100 ml and 200 ml (100 ml is currently sold).6.6 Special Precautions For Disposal And Other Handling
Oral administration.ADMINISTRATIVE DATA 7. Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Limited,
HU8 7DS.8. Marketing Authorisation Number(S)
PL 0063/0038.9. Date Of First Authorisation/Renewal Of The Authorisation
24th April, 1995.10. Date Of Revision Of The Text
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Lemsip Max All in One Lemon (Reckitt Benckiser Healthcare (UK) Ltd)
1. Name Of The Medicinal Product
Lemsip Max All in One Lemon.2. Qualitative And Quantitative Composition
200.003. Pharmaceutical Form
Powder for oral solution. Pale yellow powder.4. Clinical Particulars 4.1 Therapeutic Indications
For the relief of symptoms of colds and influenza, including the relief of aches and pains, sore throat, headache, nasal congestion, lowering of temperature and chesty coughs.4.2 Posology And Method Of Administration
Oral administration after dissolution in water. Adults and adolescents 12 years and over: One sachet dissolved by stirring in hot water and sweetened to taste. Dose may be repeated in 4-6 hours. No more than four doses should be taken in 24 hours. Not to be given to children under 12 without medical advice.4.3 Contraindications
Hypersensitivity to any of the ingredients. Severe coronary heart disease. Hypertension.4.4 Special Warnings And Precautions For Use
Use with caution in patients with Raynaud's phenomenon or diabetes mellitus. This product also contains 1973.3mg sucrose per sachet dose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Contains a source of phenylalanine. May be harmful for people with phenylketonuria. Phenylephrine should be used with care in patients with hyperthyroidism, cardiovascular disease, diabetes mellitus, closed angle glaucoma, prostatic enlargement and hypertension. Leaflet: Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage. Do not exceed the stated dose. Patients should be advised not to take other paracetamol – containing products or other cold and decongestant medicines concurrently. If symptoms persist, consult your doctor. Keep out of the reach and sight of children. If you are pregnant or are being prescribed medicine by your doctor, seek his advice before taking this product. Contains paracetamol (panel). Total sugars 2g. Immediate medical advice should be sought in the event of an overdose, even if you feel well.4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect. Phenylephrine may adversely interact with other sympathomimetics, vasodilators and beta-blockers. Drugs, which induce hepatic microsomal enzymes, such as alcohol, barbiturates, monoamine oxidase inhibitors and tricyclic antidepressants, may increase the hepatotoxicity of paracetamol, particularly after overdosage. Not recommended for patients currently receiving or within two weeks of stopping therapy with monoamine oxidase inhibitors.
Guaifenesin may increase the rate of absorption of paracetamol. Guaifenesin may interfere with diagnostic measurements of urinary 5-hydroxyindoleactic acid or vanillylmandelic acid.4.6 Pregnancy And Lactation
Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of their doctor regarding its use. Paracetamol is excreted in breast milk, but not in a clinically significant amount. Available published data do not contraindicate breast-feeding. Phenylephrine hydrochloride: Due to the vasoconstrictive properties of phenylephrine, the product should be used with caution in patients with a history of pre-eclampsia. Phenylephrine may reduce placental perfusion and the product should be used in pregnancy only if the benefits outweigh this risk. There is no information on use in lactation. Guaifenesin: Has been linked with an increased risk of neural tube defects in a small number of women with febrile illness in the first trimester of pregnancy. The product should be used in pregnancy only if the benefits outweigh this risk. There is no information on use in lactation.4.7 Effects On Ability To Drive And Use Machines
None known.4.8 Undesirable Effects
Adverse effects of paracetamol are rare, but hypersensitivity including skin rash may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol. Phenylephrine hydrochloride: High blood pressure with headache, vomiting and rarely, palpitations. Also, rare reports of allergic reactions. Guaifenesin has occasionally been reported to cause gastro-intestinal discomfort, nausea and vomiting, particularly in very high doses.4.9 Overdose
Paracetamol: Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of five or more of paracetamol may lead to liver damage if the patient has risk factors (see below).
Risk Factors If the patient: (a) Is on long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes, or (b) Regularly consumes ethanol in excess of recommended amounts, or (c) Is likely to be glutathione deplete, e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia. Symptoms: Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported. Management: Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section. Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should be discussed with the NPIS or a liver unit.
Phenylephrine hydrochloride: Features of severe overdosage of phenylephrine include haemodynamic changes and cardiovascular collapse with respiratory depression. Treatment includes early gastric lavage and symptomatic and supportive measures. Hypertensive effects may be treated with an i.v. alpha-receptor-blocking agent. Guaifenesin: Very large doses may cause nausea and vomiting. The drug is, however, rapidly metabolised and excreted in the urine. Patients should be kept under observation and treated symptomatically.5. Pharmacological Properties 5.1 Pharmacodynamic Properties
ATC Code: N02B E51.
Paracetamol: Paracetamol has both analgesic and antipyretic activity, which is believed to be mediated principally through its inhibition of prostaglandin synthesis within the central nervous system.
Phenylephrine hydrochloride: Phenylephrine is a post-synaptic alpha-receptor agonist with low cardioselective beta-receptor affinity and minimal central stimulant activity. It is a recognised decongestant and acts by vasoconstriction to reduce oedema and nasal swelling.
Guaifenesin: Guaifenesin is an expectorant which reduces the viscosity of tenacious sputum.5.2 Pharmacokinetic Properties
Paracetamol: Paracetamol is absorbed rapidly and completely from the small intestine, producing peak plasma levels after 15-20 minutes following oral dosing. The systemic availability is subject to first-pass metabolism and varies with dose between 70% and 90%. The drug is rapidly and widely distributed throughout the body and is eliminated from plasma with a T? of approximately 2 hours. The major metabolites are glucuronide and sulphate conjugates (>80%) which are excreted in urine.
Phenylephrine hydrochloride: Phenylephrine is absorbed from the gastrointestinal tract, but has reduced bioavailability by the oral route due to first-pass metabolism. It retains activity as a nasal decongestant when given orally, the drug distributing through the systemic circulation to the vascular bed of the nasal mucosa. When taken by mouth as a nasal decongestant phenylephrine is usually given at intervals of 4-6 hours.
Guaifenesin: Guaifenesin is absorbed from the gastrointestinal tract. It is rapidly metabolised by oxidation to ?-(2 methoxy-phenoxy) lactic acid; which is excreted in the urine.5.3 Preclinical Safety Data
None available specific to the product.6. Pharmaceutical Particulars 6.1 List Of Excipients
Lemon flavour no. 1
Curcumin WD6.2 Incompatibilities
None Known6.3 Shelf Life
Two years.6.4 Special Precautions For Storage
Do not store above 25°C. Store in the original package.6.5 Nature And Contents Of Container
Heat-sealed sachet of paper/polyethylene/aluminium foil/ polyethylene laminate in an outer cardboard carton. Packs: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 sachets.6.6 Special Precautions For Disposal And Other Handling
Not applicable.7. Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, Hull, HU8 7DS, East Yorkshire, United Kingdom.8. Marketing Authorisation Number(S)
PL 00063/0168.9. Date Of First Authorisation/Renewal Of The Authorisation
18/12/200610. Date Of Revision Of The Text
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Zocor Heart-Pro 10mg tablets
1. Name Of The Medicinal Product
ZOCOR Heart-Pro® 10mg tablets2. Qualitative And Quantitative Composition
Simvastatin 10 mg
For a full list of excipients see section 6.1.3. Pharmaceutical Form
Peach-coloured, oval-shaped tablets marked 'MSD-735'.4. Clinical Particulars 4.1 Therapeutic Indications
To reduce the risk of a first major coronary event (non fatal myocardial infarction and coronary heart disease (CHD) deaths) in individuals who are likely to be at moderate risk (approximately 10-15% 10-year risk of a first major event) of CHD, i.e.:
• Men aged 55 years and above.
• Men aged 45-54 years and women aged 55 years and above who have one or more of the following:
o Family history of coronary heart disease in a first-degree relative (parent or sibling); CHD in male first degree relative below 55 years or female first degree relative below 65 years.
o Smoker (is currently a smoker or has been a smoker in the last 5 years).
o Overweight (Body Mass Index> 25kg/m2) or truncal obesity (waist: 40 inches or 102cm in men; 35 inches or 88cm in women).
o Of South Asian ethnic origin i.e. from the Indian subcontinent that includes India, Bangladesh, Pakistan or Sri Lanka.
Zocor Heart-Pro® should be taken as part of a programme of actions designed to reduce the risk of CHD. These include cessation of smoking, eating a healthy diet, weight loss and regular exercise.4.2 Posology And Method Of Administration
Route of administration is oral.
Zocor Heart-Pro® is given as a single 10mg dose in the evening.
Simvastatin treatment can be initiated simultaneously with diet, exercise and smoking cessation.
Use in the elderly: No dosage adjustment is necessary.
Children: The experience in children is limited. Zocor Heart-Pro® is not indicated for paediatric use.4.3 Contraindications
Hypersensitivity to simvastatin or any of the excipients; previous history of muscular toxicity with a statin or fibrate; individuals already taking prescription cholesterol lowering drugs; concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin and nefazodone); active liver disease or unexplained persistent elevations of serum transaminases; pregnancy and breast feeding (see also 4.6 'Pregnancy and lactation'); women of childbearing potential.4.4 Special Warnings And Precautions For Use
Zocor Heart-Pro® treatment is not intended for individuals who are known to have:
• Existing coronary heart disease
• History of stroke or peripheral vascular disease
• Diagnosis of the genetic disorder called Familial Hypercholesterolaemia
Individuals with these conditions are at higher risk of cardiovascular disease and should be managed under the supervision of a physician.
Individuals who have been diagnosed as having hypertension are also at increased risk of cardiovascular disease. Therefore, these individuals should consult their doctor before undertaking treatment with Zocor Heart-Pro®.
If an individual is found to have a fasting LDL-C level of 5.5 mmol/l or greater before or during treatment, they should be advised to consult their doctor, since it is unlikely that simvastatin 10mg will give a satisfactory reduction in cholesterol.
Reducing the risk of myopathy:
Simvastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ten times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria and very rarely fatalities have occurred.
1. General measures
All individuals starting therapy with Zocor Heart-Pro® must be advised of the risk of myopathy and told to immediately stop taking Zocor Heart-Pro® until they consult with a physician, if they experience unexplained generalised muscle pain, tenderness or weakness (e.g. muscle pain not associated with flu, unaccustomed exercise, or recent strain or injury). A creatine kinase (CK) level should be measured in people with these symptoms.
Simvastatin therapy should be discontinued immediately if myopathy is diagnosed or suspected. The presence of these symptoms and/or a CK level>10 times the upper limit of normal indicates myopathy. In most cases, when patients were promptly discontinued from treatment, muscle symptoms and CK increases resolved.
Many of the patients who have developed rhabdomyolysis on therapy with simvastatin have had complicated medical histories, including renal insufficiency usually as a consequence of long-standing diabetes. Such patients merit closer monitoring (see 4.4, Special warnings and precautions for use). Also, as there are no known adverse consequences of brief interruption of therapy, treatment with simvastatin should be stopped a few days before elective major surgery and when any major acute medical or surgical condition supervenes.
People aged>70 years or with hypothyroidism, renal impairment, a personal or family history of hereditary muscle disorders should not take Zocor Heart-Pro® except on medical advice.
2. Measures to reduce the risk of myopathy caused by drug interactions (see above)
Use of simvastatin concomitantly with itraconazole, ketoconazole, erythromycin, telithromycin, clarithromycin, HIV protease inhibitors or nefazodone, should be avoided. If treatment with itraconazole, ketoconazole, erythromycin, telithromycin or clarithromycin is unavoidable, therapy with simvastatin should be suspended during the course of treatment. Concomitant use with other medicines labelled as having a potent inhibitory effect on CYP3A4 at therapeutic doses should be avoided unless the benefits of combined therapy outweigh the increased risk. (See 4.5 Interactions with other medicinal products and other forms of interaction).
The risk of myopathy, including rhabdomyolysis, may be increased by concomitant administration of fusidic acid with statins (section 4.5). If the combination proves necessary, patients on fusidic acid and simvastatin should be closely monitored (see section 4.5). Temporary suspension of simvastatin treatment may be considered.
Interstitial Lung Disease: Exceptional cases of interstitial lung disease have been reported with some statins, especially with long term therapy (see section 4.8). Presenting features can include dyspnoea, non productive cough and deterioration in general health (fatigue, weight loss and fever). If it is suspected a patient has developed interstitial lung disease, statin therapy should be discontinued.
Hepatic effects: In clinical studies with higher doses of simvastatin, persistent increases (to more than 3X ULN) in serum transaminases have occurred in a few adult patients who received simvastatin. These changes appear to be less common with lower doses. When the drug was interrupted or discontinued in these patients, the transaminase levels usually fell slowly to pre-treatment levels.
As with other lipid lowering agents, moderate (less than 3X ULN) elevations of serum transaminase have been reported following therapy with simvastatin. These changes appeared soon after initiation of therapy with simvastatin, were often transient, were not accompanied by any symptoms and interruption of treatment was not required.
The drug should be used with caution in patients who consume substantial quantities of alcohol and/or have a known past history of liver disease. Individuals consuming more than the nationally recommended upper limit for weekly units of alcohol (28 for men and 21 for women) should not take Zocor Heart-Pro® without medical supervision. Active liver diseases or unexplained persistent transaminase elevations are contra-indications to the use of simvastatin.
If an individual develops symptoms or signs of liver disease (e.g. jaundice) while taking Zocor Heart-Pro® the drug should be discontinued immediately and medical advice should be sought.
This product contains lactose. Individuals with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Interaction studies have only been performed in adults.
Interactions with lipid-lowering medicinal products that can cause myopathy when given alone.
The risk of myopathy, including rhabdomyolysis, is increased during the concomitant administration with fibrates and niacin (nicotinic acid) (
Prescribing recommendations for interacting agents are summarised in the table below (further details are provided in the text; see also sections 4.3 and 4.4).Drug Interactions Associated with Increased Risk of Myopathy/Rhabdomyolysis
Potent CYP3A4 inhibitors:
HIV protease inhibitors
Contraindicated with simvastatin
Avoid but if necessary, do not exceed 10 mg simvastatin daily
Other fibrates (except fenofibrate)
Do not exceed 10 mg simvastatin daily
Patients should be closely monitored. Temporary suspension of simvastatin treatment may be considered.
Avoid grapefruit juice when taking simvastatin
Effects of other medicinal products on simvastatin.
Interactions involving CYP3A4.
Simvastatin is a substrate of cytochrome P450 3A4. Potent inhibitors of cytochrome P450 3A4 increase the risk of myopathy and rhabdomyolysis by increasing the concentration of HMG-CoA reductase inhibitory activity in plasma during simvastatin therapy. Such inhibitors include itraconazole, ketoconazole, erythromycin, telithromycin, clarithromycin, HIV protease inhibitors and nefazodone. Concomitant administration of itraconazole resulted in a more than 10 fold increase in exposure to simvastatin acid (the active beta-hydroxyacid metabolite). Telithromycin caused an 11
The risk of myopathy/rhabdomyolysis is increased by concomitant administration of ciclosporin particularly with higher doses of simvastatin (see section 4.4). Therefore, the dose of simvastatin should not exceed 10 mg daily in patients receiving concomitant medication with ciclosporin. Although the mechanism is not fully understood, ciclosporin has been shown to increase the AUC of HMG-CoA reductase inhibitors. The increase in AUC for simvastatin acid is presumably due, in part, to inhibition of CYP3A4.
The risk of myopathy and rhabdomyolysis is increased by concomitant administration of danazol with higher doses of simvastatin. Therefore, the dose of simvastatin should not exceed 10 mg daily in patients receiving concomitant medication with danazol
Gemfibrozil increases the AUC of simvastatin 1.9-fold possibly due to inhibition of the glucuronidation pathway (see section 4.4). Therefore the dose of simvastatin should not exceed 10 mg daily in patients receiving concomitant medication with gemfibrozil.
The risk of myopathy may be increased by concomitant administration of fusidic acid with statins, including simvastatin. Isolated cases of rhabdomyolysis have been reported with simvastatin. Temporary suspension of simvastatin treatment may be considered. If it proves necessary, patients on fusidic acid and simvastatin should be closely monitored (see section 4.4).
Grapefruit juice inhibits cytochrome P450 3A4. Concomitant intake of large quantities (over 1 litre daily) of grapefruit juice and simvastatin resulted in a 7-fold increase in exposure to simvastatin acid. Intake of 240 ml of grapefruit juice in the morning and simvastatin in the evening also resulted in a 1.9-fold increase. Intake of grapefruit juice during treatment with simvastatin should therefore be avoided.
Effects of simvastatin on the pharmacokinetics of other medicinal products.
Simvastatin does not have an inhibitory effect on cytochrome P450 3A4. Therefore, simvastatin is not expected to affect plasma concentrations of substances metabolised via cytochrome P450 3A4.
In two clinical studies, one in normal volunteers and the other in hypercholesterolaemic patients, simvastatin 20-40 mg/day modestly potentiated the effect of coumarin anticoagulants: the prothrombin time, reported as International Normalised Ratio (INR), increased from a baseline of 1.7 to 1.8 and from 2.6 to 3.4 in the volunteer and patient studies, respectively. Very rare cases of elevated INR have been reported. In patients taking coumarin anticoagulants, prothrombin time should be determined before starting simvastatin and frequently enough during early therapy to ensure that no significant alteration of prothrombin time occurs.
Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals usually recommended for patients on coumarin anticoagulants. If the dose of simvastatin is changed or discontinued, the same procedure should be repeated. Simvastatin therapy has not been associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants.4.6 Pregnancy And Lactation
Zocor Heart-Pro® is contra-indicated during pregnancy (see section 4.3).
Safety in pregnant women has not been established. No controlled clinical trials with simvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG
Although there is no evidence that the incidence of congenital anomalies in offspring of patients taking Zocor Heart-Pro® or another closely related HMG(See section 4.3 and 5.3.)
It is not known whether simvastatin or its metabolites are excreted in human milk. Simvastatin should be avoided during lactation.4.7 Effects On Ability To Drive And Use Machines
Simvastatin has no or negligible influence on the ability to drive and use machines. However, when driving vehicles or operating machines, it should be taken into account that dizziness has been reported rarely in post-marketing experiences.4.8 Undesirable Effects
Simvastatin is generally well tolerated; for the most part, side effects have been usually mild and transient in nature. Less than 2% of patients on simvastatin were discontinued from controlled clinical studies due to side effects attributable to simvastatin.
In the pre-marketing controlled clinical studies, the most commonly reported side effects were abdominal pain, constipation, flatulence, asthenia and headache.
The following adverse effects have been reported:
Blood and lymphatic system disorders:
Nervous system disorders:
Headache, paraesthesia, dizziness, peripheral neuropathy
Constipation, abdominal pain, flatulence, dyspepsia, diarrhoea, nausea, vomiting, pancreatitis
Hepatitis/jaundice, hepatic failure
Skin and subcutaneous tissue disorders:
Rash, pruritus, alopecia
Musculoskeletal, connective tissue and bone disorders:
Myopathy, rhabdomyolysis (see section 4.4), myalgia, muscle cramps
General disorders and administration site conditions:
An apparent hypersensitivity syndrome has been reported rarely which has included some of the following features: angioedema, lupus-like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, thrombocytopenia, eosinophilia, ESR increased, arthritis and arthralgia, urticaria, photosensitivity, fever, flushing, dyspnoea, and malaise.
Increases in serum transaminases (alanine aminotransferase, aspartate aminotransferase, ?-glutamyl transpeptidase) (see section 4.4 Hepatic effects), elevated alkaline phosphatase; increases in serum CK levels (see section 4.4).
The following adverse events have been reported with some statins:
• Sleep disturbances, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• Exceptional cases of interstitial lung disease, especially with long term therapy (see section 4.4)4.9 Overdose
To date, a few cases of overdosage have been reported; the maximum dose taken was 3.6g. All patients recovered without sequelae. There is no specific treatment in the event of overdose. In this case, symptomatic and supportive measures should be adopted.5. Pharmacological Properties 5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: Serum lipid reducing agents
ATC Code: C10 AA01
The involvement of LDL cholesterol in atherogenesis has been well documented in clinical and pathological studies, as well as in many animal experiments. Epidemiological studies have established that high LDL cholesterol and low HDL (high-density lipoprotein) cholesterol are both risk factors for coronary heart disease.
Simvastatin 10 mg/day reduces Low Density Lipoprotein Cholesterol (LDL-C) by around 27%. This degree of reduction has been shown to reduce the risk of a first major coronary event by about one third after 3 years of treatment.
After oral ingestion, simvastatin, which is an inactive lactone, is hydrolysed in the liver to the corresponding active beta-hydroxyacid form which has a potent activity in inhibiting HMG-CoA reductase (3 hydroxy-3 methylglutaryl CoA reductase). This enzyme catalyses the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in the biosynthesis of cholesterol.
Zocor Heart-Pro® has been shown to reduce both normal and elevated LDL-C concentrations. LDL is formed from very-low-density protein (VLDL) and is catabolised predominantly by the high-affinity LDL receptor. The mechanism of the LDL-lowering effect of Zocor Heart-Pro® may involve both reduction of VLDL-cholesterol (VLDL-C) concentration and induction of the LDL receptor, leading to reduced production and increased catabolism of LDL-C. Apolipoprotein B also falls substantially during treatment with Zocor Heart-Pro®. In addition, Zocor Heart-Pro® moderately increases HDL-C and reduces plasma TG. As a result of these changes the ratios of total to HDL-C and LDL- to HDL-C are reduced.5.2 Pharmacokinetic Properties
Simvastatin is an inactive lactone which is readily hydrolysed in vivo to the corresponding ?-hydroxyacid, L-654,969, a potent inhibitor of HMG-CoA reductase. Inhibition of HMG-CoA reductase is the basis for an assay in pharmacokinetic studies of the ?-hydroxyacid metabolites (active inhibitors) and, following base hydrolysis, active plus latent inhibitors (total inhibitors). Both are measured in plasma following administration of simvastatin.
In a disposition study with 14C-labelled simvastatin, 100 mg (20 uCi) of drug was administered as capsules (5 x 20 mg), and blood, urine, and faeces collected. Thirteen per cent of the radioactivity was recovered in the urine and 60% in faeces. The latter represents absorbed drug equivalents excreted in bile as well as any unabsorbed drug. Less than 0.5% of the dose was recovered in urine as HMG-CoA reductase inhibitors. In plasma, the inhibitors account for 14% and 28% (active and total inhibitors) of the AUC of total radioactivity, indicating that the majority of chemical species present were inactive or weak inhibitors.
The major metabolites of simvastatin present in human plasma are L-654,969 and four additional active metabolites. Both simvastatin and L-654,969 are highly bound to human plasma proteins (>94%). The availability of L-654,969 to the systemic circulation following an oral dose of simvastatin was estimated using an i.v. reference dose of L
In dose-proportionality studies, utilising doses of simvastatin of 5, 10, 20, 60, 90 and 120 mg, there was no substantial deviation from linearity of AUC of inhibitors in the general circulation with an increase in dose. Relative to the fasting state, the plasma profile of inhibitors was not affected when simvastatin was administered immediately before a test meal.
The pharmacokinetics of single and multiple doses of simvastatin showed that no accumulation of drug occurred after multiple dosing. In all of the above pharmacokinetic studies, the maximum plasma concentration of inhibitors occurred 1.3 to 2.4 hours post-dose.5.3 Preclinical Safety Data
Based on conventional animal studies regarding pharmacodynamics, repeated dose toxicity, genotoxicity and carcinogenicity, there are no other risks for the individual than may be expected on account of the pharmacological mechanism. At maximally tolerated doses in both the rat and the rabbit, simvastatin produced no foetal malformations and had no effects on fertility, reproductive function or neonatal development.6. Pharmaceutical Particulars 6.1 List Of Excipients
Ascorbic acid (E300)
Butylated hydroxyanisole (E320)
Citric acid monohydrate (E330)
Magnesium stearate (E572)
Microcrystalline cellulose (E460)
Pregelatinised maize starch
Titanium dioxide (E171)
Red iron oxide (E172)
Yellow iron oxide (E172)6.2 Incompatibilities
Not applicable.6.3 Shelf Life
2 years.6.4 Special Precautions For Storage
Do not store above 30°C.6.5 Nature And Contents Of Container
Blister packs of opacified trilaminate film composed of polyvinylchloride/polyethylene/polyvinylidene chloride (PVC/PE/PVDC) lidded with aluminium foil containing 28 tablets.6.6 Special Precautions For Disposal And Other Handling
No special requirements.7. Marketing Authorisation Holder
McNeil Products Limited
United Kingdom8. Marketing Authorisation Number(S)
PL 15513/03519. Date Of First Authorisation/Renewal Of The Authorisation
26 October 200910. Date Of Revision Of The Text
29 October 2009
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Antifungal; synthetic allylamine structurally and pharmacologically related to terbinafine.1 3 4 5 9 11 13 14 16 21 22 23 25 29 31 35 36 37 38 41 42 43 48 63 64 65 66 67 68 69Uses for Naftifine Hydrochloride Dermatophytoses
Treatment of tinea corporis (body ringworm)1 22 39 46 48 49 50 51 54 55 63 and tinea cruris (jock itch)1 22 23 39 45 48 49 50 51 54 55 63 caused by Epidermophyton floccosum,1 39 45 47 49 50 51 53 63 Microsporum canis†,49 50 55 Trichophyton mentagrophytes,1 39 47 49 50 51 53 55 63 T. rubrum,1 T. tonsurans,a T. verrucosum†,50 51 53 or T. violaceum†.50
Treatment of tinea pedis (athlete's foot)1 15 28 47 48 49 51 54 55 63 or tinea manuum†51 54 55 caused by Epidermophyton floccosum,1 39 45 47 49 50 51 53 63 Microsporum canis†,49 50 55 Trichophyton mentagrophytes,1 39 47 49 50 51 53 55 63 T. rubrum,1 T. tonsurans,a T. verrucosum†,50 51 53 or T. violaceum†.50
Topical antifungals usually effective for treatment of uncomplicated tinea corporis and tinea cruris.69 70 71 72 73 An oral antifungal may be necessary when tinea corporis or tinea cruris is extensive, dermatophyte folliculitis is present, the infection is chronic or does not respond to topical therapy, or the patient is immunocompromised because of coexisting disease or concomitant therapy.69 70 71 72 73
Topical antifungals usually effective for treatment of uncomplicated tinea pedis.69 70 71 72 73 An oral antifungal may be necessary for the treatment of hyperkeratotic areas on the palms and soles,70 73 for chronic moccasin-type (dry-type) tinea pedis,69 70 72 and for tinea unguium (fingernail or toenail dermatophyte infections, onychomycosis).69 70 71 72
Gel has been used in the treatment of tinea unguium (onychomycosis)†.57Cutaneous Candidiasis†
Treatment of cutaneous candidiasis† caused by Candida albicans.47 50 51 53 54 55 56 62 Less active than imidazole derivatives.36 37 56Naftifine Hydrochloride Dosage and Administration Administration Topical Administration
Apply topically to the skin as a cream or gel.1 63
Do not apply to the eye, nose, mouth, or other mucous membranes.1 63
Do not use with occlusive dressings or wrappings, unless otherwise directed by clinician.1 63
Apply a sufficient amount of topical cream or gel; rub gently into the affected area and surrounding skin.1 22 33 39 46 47 49 50 51 53 54 60 63
Wash hands after applying.1 63Dosage
Available as naftifine hydrochloride; dosage expressed in terms of naftifine.aAdults Dermatophytoses Tinea Corporis or Tinea Cruris Topical
Cream: Apply once daily for 2–4 weeks.1 15 22 25 33 39 45 46 49 53 54 60
Gel: Apply twice daily (morning and evening) for 2–4 weeks.22 25 39 45 46 49 a
Clinical improvement usually occurs within the first week of treatment.22 25 39 45 If clinical improvement does not occur after 4 weeks of treatment, reevaluate diagnosis.1 63 Severe infections may require prolonged treatment.50 60 61Tinea Pedis Topical
Cream: Apply once daily for 4–6 weeks.1 15 22 15 25 33 39 45 46 47 49 53 54 60
Gel: Apply twice daily (morning and evening) for 4–6 weeks.15 22 25 39 45 46 47 49 a
Clinical improvement usually occurs within the first week of treatment.22 25 39 45 If clinical improvement does not occur after 4 weeks of treatment, reevaluate diagnosis.1 63 Severe infections may require prolonged treatment.50 60 61Special Populations
No special population dosage recommendations at this time.aCautions for Naftifine Hydrochloride Contraindications
Known hypersensitivity to naftifine or any ingredient in the formulation. 1 63Warnings/Precautions Warnings Administration Precautions
For external use only.1 63 Use only for topical application to the skin; not for ophthalmic use.1 63
Avoid contact with eyes, nose, mouth, and other mucous membranes.1 63Sensitivity Reactions
Contact dermatitis has been reported occasionally.20 39 49 54 56
If irritation or sensitivity occurs, discontinue drug and initiate appropriate therapy.1 63General Precautions Selection and Use of Antifungals
Prior to use, confirm diagnosis by direct microscopic examination of scrapings from infected tissue mounted in potassium hydroxide (KOH) or by culture.1 63Specific Populations Pregnancy
Not known whether distributed into milk following topical application.1 63 Use with caution.1 63Pediatric Use
Safety and efficacy not established.aCommon Adverse Effects
Burning, stinging.1 22 32 39 46 47 50 51 55 63Interactions for Naftifine Hydrochloride
No formal drug interaction studies to date.Naftifine Hydrochloride Pharmacokinetics Absorption Bioavailability
Following topical application, approximately 3–6% absorbed.1 43 63Distribution Extent
Not known whether naftifine crosses the placenta.60
Distributed into milk in rats; not known whether distributed into human milk.1 43 60 63Elimination Metabolism
Metabolized by oxidation and by N-dealkylation.18Elimination Route
Systemically absorbed drug excreted in urine (40–60%) as unchanged drug and metabolites and in feces.1 18 43 63Half-life
2–3 days.1 60 63Stability Storage Topical Cream
<30°C;1 cream is stable for 24 months after the date of manufacture.60Gel
Room temperature.63Actions and SpectrumActions
Allylamine antifungal.1 3 4 5 9 11 13 14 16 21 22 23 25 29 31 35 36 37 38 41 42 43 48 63
Usually fungicidal against susceptible dermatocytes.1 9 14 41 42 Usually fungistatic against Candida; may be fungicidal at high concentrations.1 3 9 14 41 42
Exact mechanism unknown; 1 3 11 16 41 43 appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene monooxygenase (squalene 2,3-epoxidase).1 11 13 14 16 21 41 43 The resulting accumulation of squalene (the usual substrate of the enzyme) in the cells and decreased amounts of sterols, especially ergosterol,1 3 10 11 16 41 may contribute to the antifungal effects.41
Spectrum of antifungal activity includes many fungi, including dermatophytes and yeasts.1 2 3 4 5 8 9 12 22 23 31 37 42 Also may have in vitro activity against some gram-positive and -negative bacteria,58 60 61 and Leishmania.27
Candida: Active in vitro against Candida albicans,1 3 4 12 36 C. krusei,4 C. parapsilosis,4 12 31 41 and C. tropicalis;12 however, less active than imidazole derivatives against Candida.36 37 56
Dermatophytes and other fungi: Active in vitro against Aspergillus flavus,12 A. fumigatus,12 Blastomyces dermatitidis,12 Cryptococcus neoformans,12 Epidermophyton floccosum,1 4 8 12 38 42 Histoplasma capsulatum,12 Microsporum audouinii,1 M. canis,1 8 38 42 M. gypseum,1 8 Petriellidium boydii,12 Sporothrix schenckii,4 12 Trichophyton mentagrophytes,1 2 8 38 41 42 T. rubrum,1 8 38 42 T. tonsurans,1 38 T. verrucosum,42 and T. violaceum.8 38
Also has anti-inflammatory activity when applied topically.51 52
No reports to date of resistance in organisms originally susceptible to naftifine.60 61Advice to Patients
Importance of completing full course of treatment, even if symptoms improve.1
Importance of contacting clinician if improvement does not occur within 4 weeks.1 63
Importance of notifying clinician if condition worsens or treated area shows signs of increased irritation.a
Importance of applying to affected areas as directed and avoiding contact with eyes, nose, mouth, or other mucous membranes.1 63
Advise patients to wash their hands after touching the affected areas.a
Importance of not using occlusive dressings, unless otherwise directed by clinician.1 63
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.a
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.a
Importance of informing patients of other important precautionary information. (See Cautions.)Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.Naftifine Hydrochloride
Naftin (with benzyl alcohol)
Naftin (with alcohol 52% v/v)
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Naftin 1% Cream (MERZ PHARMACEUTICAL): 30/$109.99 or 90/$285.96
Naftin 1% Cream (MERZ PHARMACEUTICAL): 60/$190 or 180/$559.94
Naftin 1% Cream (MERZ PHARMACEUTICAL): 90/$239.98 or 270/$676
Naftin 1% Gel (MERZ PHARMACEUTICAL): 40/$155.99 or 120/$435.96
Naftin 1% Gel (MERZ PHARMACEUTICAL): 90/$269.99 or 270/$769.94
Naftin 1% Gel (MERZ PHARMACEUTICAL): 60/$216 or 180/$589.99Disclaimer
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 January 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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a. Merz Pharmaceuticals. Naftin (naftifine hydrochloride 1%) gel and cream prescribing information. Greensboro, NC; 2007 May.More Naftifine Hydrochloride resources Naftifine Hydrochloride Side Effects (in more detail) Naftifine Hydrochloride Dosage Naftifine Hydrochloride Use in Pregnancy & Breastfeeding Naftifine Hydrochloride Support Group 2 Reviews for Naftifine Hydrochloride - Add your own review/rating Compare Naftifine Hydrochloride with other medications Tinea Corporis Tinea Cruris Tinea Pedis
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