Permethrin 5% w/w Cream Taj Pharma

Permethrin 5% w/w Cream

1. Name of the medicinal product

Permethrin 5% w/w Cream Taj Pharma

2. Qualitative and quantitative composition

Permethrin, Medical Grade 5.0% w/w

For excipients, see 6.1

3. Pharmaceutical form

Cream for topical application.

4. Clinical particulars

4.1 Therapeutic indications

Permethrin 5% w/w Cream is indicated for the treatment of scabies in adults and children >2 months of age, and crab lice in adults.

4.2 Posology and method of administration

Treatment of scabies

Adults and adolescents over 12 years of age:

Apply up to 30 g of cream (corresponding to one tube of 30 g).

Paediatric population

Children aged from 6 – 12 years:

Apply up to 15 g of cream (corresponding to ½ tube of 30 g).

Children aged from 2 months – 5 years:

Up to 7.5 g of cream (corresponding to ¼ tube of 30 g).

The safety and efficacy of Permethrin 5% w/w Creamin children under 2 months of age have not been established. No data are available.

Treatment of crab lice

Adults over 18 years of age:

Apply up to 30 g of cream (corresponding to one tube of 30 g).

Method of administration

For cutaneous use only. The medicinal product must not be swallowed.

Carefully apply a thin layer of cream to the skin (cutaneous use).

For treatment of scabies:

Adults should apply the cream uniformly to the whole body including the neck, palms of the hands and soles of the feet. The head and face can be spared unless scabies efflorescences are present in this region.

On application, the areas between the fingers and toes (also under the finger- and toe-nails), the wrists, elbows, armpits, external genitalia and the buttocks should be especially carefully treated.

Paediatric population

Children should apply the cream uniformly to the whole body, including the palms of the hands, soles of the feet, neck, face,

ears, and scalp. Parts of the skin around the mouth (because the cream could be licked off) and the eyes should be spared. Children should be kept from licking the cream from the hands. If necessary, children should wear gloves.

Only limited experience is available with Permethrin 5% w/w Cream in children aged 2 months to 23 months. Therefore treatment must be given only under close medical supervision in this age group.

Elderly:

Elderly patients (over 65 years) should use the cream in the same way as adults, but in addition, the face, ears and scalp should also be treated. Care should be taken to avoid applying the cream to areas of skin around the eyes.

Permethrin 5% w/w Cream should be applied to clean, dry, cool skin. If the patient has taken a warm bath prior to treatment the skin should be allowed to cool before the cream is applied.

Permethrin 5% w/w Cream is a vanishing cream and when rubbed gently into the skin it will disappear. Therefore, there is no need to continue to apply cream to the skin until it remains detectable on the surface.

Older children should be supervised by an adult when applying to ensure that a thorough treatment is administered.

The whole body should be washed thoroughly 8 – 12 hours after treatment.

Approximately 90% of individuals are cured with a single application of cream. If necessary, a second application may be given not less than 7 days after the initial application, if there are no signs of the original lesions healing or if new lesions are present.

For treatment of crab lice in adults:

Sufficient cream should be applied to cover the pubic region, peri-anal (around the anus), inner thighs down to the knees and any hair that grows up from the pubic area to the chest/stomach.

For treatment of crab lice in adults, the cream should be left on the skin for 24 hours, after which the treatment areas should be washed thoroughly.

Any facial hair (beards, moustaches) and eyelashes should be checked for the presence of live lice and eggs. Cream should be applied to any facial hair, carefully avoiding eyes. If live lice or eggs are found on the eyelashes they should be removed carefully using tweezers. Cream should not be applied to the eyelashes because the cream can cause moderate eye irritation.

4.3 Contraindications

Hypersensitivity to the active substance permethrin or other substances of the pyrethrin group or to any of the excipients listed in section 6.1. In such cases treatment should be switched to a chemically different antiscabies agent.

4.4 Special warnings and precautions for use

In the case of hypersensitivity to chrysanthemums or other compositae, treatment should only be given if strictly indicated. In such cases treatment should be switched to a chemically different agent.

When using Permethrin 5% w/w Cream5%, care should be taken not to allow the cream to get into the eyes or come into contact with mucous membranes (e.g. nasopharyngeal space, genital area) or open wounds.

Paediatric population

Only limited experience is available with Permethrin 5% w/w Cream in children aged 2 months to 23 months. Therefore treatment must be given only under close medical supervision in this age group.

For cutaneous use only!

Permethrin 5% w/w Cream5% is harmful to all types of insects and also for aquatic forms of life (fishes, daphnia, algae). Contamination of aquaria and terraria is to be avoided.

Note: The excipients of the cream (liquid paraffin, white soft paraffin) can reduce the functioning and hence the reliability of latex products (e.g. condoms, diaphragms) used at the same time.

4.5 Interaction with other medicinal products and other forms of interaction

No interactions are known.

The treatment of eczematous-like reactions with corticosteroids should be withheld prior to treatment with Permethrin 5% w/w Cream, as there is a risk of exacerbating the scabies infestation by reducing the immune response to the mite. The likelihood of interactions between the two treatments leading to potentiated adverse reactions or reduced efficacy is, however, small.

4.6 Pregnancy and lactation

There are limited data on the use of Permethrin 5% w/w Cream in pregnancy which provide no indication of any risk to the foetus. Furthermore the amount of permethrin absorbed systemically following a whole body application is extremely low. Some permethrin may cross the placental barrier. The negative mutagenicity tests and the very low mammalian toxicity would suggest that any risk to the foetus following treatment with Permethrin 5% w/w Cream is minimal.

Studies, following oral administration of permethrin in cattle have indicated that very low concentrations of permethrin are excreted in milk. It is not known whether permethrin is excreted in human breast milk. However, because only extremely small amounts of permethrin are absorbed systemically following treatment with Permethrin 5% w/w Cream and in theory only a very small percentage of this systemic permethrin may pass into the breast milk, it is unlikely that the concentrations of permethrin in the milk will present any risk to the neonate/infant.

Reproduction studies in mice, rats and rabbits given oral dosage of 200 to 400 mg/kg bodyweight/day, revealed no evidence of impaired fertility. In addition, permethrin did not show any adverse effects on the reproductive function of rats given an oral dosage of 180 mg/kg bodyweight/day, in a three generation study.

There was no evidence of teratogenicity in reproduction studies in mice, rats and rabbits.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

In scabies patients, skin discomfort, usually described as burning, stinging or tingling, occurs in a few individuals soon after Permethrin 5% w/w Cream is applied. This occurs more frequently in patients with severe scabies and is usually mild and transient.

Other transient signs and symptoms of irritation, including erythema, oedema, eczema, rash and pruritus which may follow treatment of scabies with Permethrin 5% w/w Cream are generally considered to be part of the natural history of scabies.

In patients treated for scabies, itching may persist for up to 4 weeks post-treatment. This is generally regarded as due to an allergic reaction to the dead mites under the skin and is not necessarily indicative of a treatment failure.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

There are no reports of overdosage with Permethrin 5% w/w Cream.

Application of a full tube of cream to a 2 month old would result in a dose of approximately 350 mg/kg bodyweight to skin. It is unlikely that such a dose would cause overt signs of systemic toxicity even if 100% of the permethrin were absorbed.

It is possible that excessive application of Permethrin 5% w/w Cream might result in localised adverse reactions or more severe skin reactions.

Symptomatic treatment is indicated should hypersensitivity-type reactions occur.

In the event of accidental ingestion of the contents of a tube of Permethrin 5% w/w Cream by a child, gastric lavage should be considered if consultation is within 2 hours of ingestion.

5. Pharmacological properties

5.1 Pharmacodynamic properties

The principal physiological action in insects (lice) exposed to permethrin is induction of electrochemical abnormalities across the membranes of excitable cells, leading to sensory hyperexcitability, inco-ordination and prostration. It is assumed that the mode of action against arachnids (mites) is similar.

Paediatric population

Newborns and infants:

The safety and efficacy of permethrin in newborns and infants under 2 months of age have not been established since no data are available from prospective trials or larger case series. A limited number of case reports in the treatment of children under 2 months of age presenting with scabies do not suggest specific safety concerns for the use of topical permethrin in this age group, but no definite conclusion can be drawn.

5.2 Pharmacokinetic properties

Investigations with the 5 % cream in humans revealed an average percutaneous absorption rate of 0.47 ± 0.3 % in healthy subjects and of 0.52 ± 0.3 % in patients.

Pharmacokinetic properties were studied in adult subjects only (6 healthy volunteers and 6 patients with scabies).

Absorbed permethrin is rapidly broken down by esterases as well as hydrolases. After oral administration, peak plasma concentrations are reached in approximately 4 hours. The isomeric mixture is then excreted in the urine in the form of glucuronides, sulfates etc as cis- trans CI2CA [(3- (2,2-dichlorovinyl)-2,2-dimethylcyclopropane-1-carboxylic acid)] and after oxidation to 3 PBA (3- phenoxybenzoic acid). After oral application, up to 6 % is excreted unchanged in the faeces whilst on dermal application, unchanged permethrin is virtually undetectable.

5.3 Preclinical safety data

From acute and chronic toxicity studies there is no evidence indicating the occurrence of previously unknown adverse effects in humans. Furthermore there is no evidence on relevant genotoxic or carcinogenic potential. In studies on the reproductive toxicity in mice, rats and rabbits after repeated oral administration of permethrin effects were observed only for doses largely exceeding the exposure expected for the topical use of the 5% cream. Following the intended use of this active substance a serious harmful effect on aquatic organisms (daphnia and fish) and terrestric organisms (plants) is expected after passage of the sewage treatment plant.

6. Pharmaceutical particulars

6.1 List of excipients

Fractionated coconut oil, Glyceryl monostearate, Macrogol (2) cetyl ether, Cetomacrogol 1000, Isopropyl myristate, Lanolin alcohols/liquid paraffin, Mixture (amerchol 1-101), Butylated hydroxytoluene, Glycerol, Formaldehyde solution, Carbomer, Sodium hydroxide, Purified water

6.2 Incompatibilities

None known

6.3 Shelf life

60 months

6.4 Special precautions for storage

Do not store above 25°C.

Do not freeze.

6.5 Nature and contents of container

Plastic foil laminate ointment tubes (30g) with Polyolefin screw caps.

Or

Internally lacquered membrane sealed collapsible aluminium tubes (30g) with high density polyethylene caps.

6.6 Special precautions for disposal and other handling

Not applicable.

7. Manufactured in India by:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of Commerce Lane,
   Fort, Mumbai – 400001
   at: Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com

Permethrin 5% w/w Cream Taj Pharma

PATIENT INFORMATION LEAFLET

Permethrin

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to use Permethrin 5% w/w Cream carefully to get the best results from it.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if the symptoms worsen or do not improve.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist straightaway.

In this leaflet:

1. What Permethrin 5% w/w Cream is and what it is used for
   2. Before you use Permethrin 5% w/w Cream
   3. How to use Permethrin 5% w/w Cream
   4. Possible side effects
   5. Storing Permethrin 5% w/w Cream
   6. Further information
2. What Permethrin 5% w/w Cream is and what it is used for

Permethrin 5% w/w Cream is used to treat infestations of scabies and crab lice on the body. It contains the ingredient permethrin which belongs to a group of medicines called pyrethroids which kill mites such as scabies and crab lice.

2. Before you use Permethrin 5% w/w Cream

Do not use Permethrin 5% w/w Cream :

• If you are allergic to Permethrin, other pyrethrins or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Permethrin 5% w/w Cream :

• If you are treating infants – see below in the section “Children up to 23 months of age”.
• If you are known to be allergic to chrysanthemums or other compositae – you should only use Permethrin 5% w/w Cream after speaking to your doctor.

Warning

For cutaneous use only! Do not swallow this medicine.

Avoid contact with eyes or mucous membranes (inside the nose or throat, genital region) or open wounds.

Permethrin 5% w/w Cream may worsen symptoms of asthma or eczema.

Children up to 23 months of age

Do not use Permethrin 5% w/w Cream in newborns and infants less than 2 months of age, unless your doctor tells you so. There is no adequate experience in infants and toddlers. Treatment to children up to 23 months of age should only be given under close medical supervision.

Taking other medicines

Corticosteroids (steroids) should not be used to treat skin conditions like eczema when Permethrin 5% w/w Cream is being used because they may make the infestation of scabies and lice worse by interfering with the body’s natural defence to scabies and crab lice.

Permethrin 5% w/w Cream is not known to interact with any medicines.

Pregnancy and breast feeding

As with all medicines, if you are pregnant or breast feeding, consult your doctor before using Permethrin 5% w/w Cream during pregnancy or while breast feeding.

Important information about some of the ingredients of Permethrin 5% w/w Cream

Permethrin 5% w/w Cream contains butylated hydroxytoluene (E321) and formaldehyde which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes (lining of the nose, mouth and genital areas).

Permethrin 5% w/w Cream contains paraffins. These excipients of the cream can reduce the efficiency and hence the reliability of latex products (e. g. condoms, diaphragms) used at the same time.

Permethrin 5% w/w Cream is harmful to all types of insects and also to animals living in water e. g. fish. Take care that Permethrin 5% w/w Cream does not get into aquaria or terraria.

3. How to use Permethrin 5% w/w Cream

Always use Permethrin 5% w/w Cream exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

To pierce tube, remove the cap and reverse it over the nozzle, push firmly and turn.

Apply the cream to clean, dry, cool skin. Do not take a hot bath or shower immediately before treatment.

Carefully apply a thin layer of cream to the skin (see “How and when should you use Permethrin 5% w/w Cream ?”).

To treat scabies

Adults and adolescents over 12 years of age. Apply up to 30 g of cream (corresponding to one tube of 30 g)

Children aged from 6 – 12 years. Apply up to 15 g of cream (corresponding to ½ tube of 30 g)

Children aged from 2 months – 5 years. Apply up to 7.5 g of cream (corresponding to ¼ tube of 30 g)

Newborns and infants under 2 months of age. There is only limited amount of data available in this age group and no dose can be recommended (see also section 2 under “warnings and precautions”).

The above information is merely a guide. The dose can be adjusted according to the needs of the individual patient and the individual body surface area. For example, some adults require a larger amount of cream.

To treat crab lice

Adults over 18 years of age: Apply up to 30 g of cream (corresponding to one tube of 30 g).

How and when should you use Permethrin 5% w/w Cream ?

Permethrin 5% w/w Cream is for cutaneous use only.

Take care not to allow the cream to get into the eyes or come into contact with mucous membranes (inside the nose or throat, genital region) or open wounds. If accidental contact occurs, rinse thoroughly with water.

Adults should apply the cream to the whole body including the neck, palms of the hands and soles of the feet. The head and face can be spared unless this area includes places affected by scabies (itch mites).

When applying the cream, the areas between the fingers and toes (also under the finger- and toe-nails), the wrists, elbows, armpits, external genitalia and buttocks should be especially carefully treated.

For treatment of crab lice in adults: Any facial hair (beards moustaches) and eyelashes should be checked for the presence of live lice and eggs. Cream should be applied to any facial hair, carefully avoiding eyes. If live lice or eggs are found on the eyelashes they should be removed carefully using tweezers. Cream should not be applied to the eye lashes because the cream can cause moderate eye irritation.

Children, Children should apply the cream uniformly to the whole body, including the palms of the hands, soles of the feet, neck, face, ears, and scalp. Parts of the skin around the mouth (because the cream could be licked off) and the eyes should be spared. Keep your child from licking the cream from the hands. If necessary, children should wear gloves.

There is no adequate experience in infants and toddlers. Treatment to children up to the age of 23 months should therefore only be treated under close medical supervision.

Elderly, Elderly patients (over 65 years) should use the cream in the same way as adults but in addition, the face, ears and scalp should also be treated. Care should be taken to avoid applying the cream to areas of skin around the eyes.

How long should you use Permethrin 5% w/w Cream ?

One application of Permethrin 5% w/w Cream is usually sufficient.

Leave the cream on the skin for at least eight hours, for example, overnight. Avoid bathing, showering or washing during this period, because this could endanger the success of treatment. If, by way of an exception, you have to wash your hands within the eight hour period, then reapply the cream to the hands and wrist area. The same applies if you have to wash other parts of treated skin (buttocks, external genitalia).

After at least eight hours, take a shower or wash the skin with soap and water.

Provided these instructions for use are followed, a single application is generally sufficient for successful treatment. However, in cases of persistent or renewed infestation, it may be necessary to repeat the treatment after 14 days.

If you use too much:

If too much cream is applied, it should be washed off with soap and warm water. If there are any signs of irritation, talk to your doctor. If the contents of the tube are swallowed by a child get medical aid from the doctor or Accident and Emergency Department of the nearest hospital immediately.

4. Possible side effects

Like all medicines, Permethrin 5% w/w Cream can cause side effects, although not everybody gets them.

If severe hypersensitivity reactions occur, please consult a doctor immediately! In this case you must not use Permethrin 5% w/w Cream any more.

Common: may affect up to 1 in 10 people.

Itching (pruritus), reddening of the skin or unusual sensations on the skin (paraesthesias) such as tingling, pricking, skin burning sensation as well as dry skin are common. However, such symptoms can also occur as a result of the disease itself. Moisturisers and oil baths are recommended as follow up treatment for dry skin. The itching and a skin rash (post-scabies eczema) may persist for up to four weeks after the end of treatment. This is caused by a reaction to the killed scabies mites. If after using Permethrin 5% w/w Cream you have the impression that the disease is persisting, please speak to your doctor before applying it again.

Rare: may affect up to 1 in 1,000 people.

Headache can occur rarely.

Very rare: may affect up to 1 in 10,000 people.

Very rarely, skin lesions (excoriations), inflammation of the hair follicles (folliculitis) and reduced skin pigmentation have been reported at the time Permethrin 5% w/w Cream is used.

Sensitive/allergic persons have reported breathing difficulties at the time substances from the pyrethrin group were being used.

Not known: frequency cannot be estimated from the available data.

Intolerability reactions may occur on the skin (contact allergy reactions) that are expressed as itching, reddening, blisters or nettle rash (urticaria). These reactions may also spread beyond the area of skin treated.

Nausea may appear. Vomiting was not reported after the use of Permethrin 5% w/w Cream but is known in connection with other permethrin-containing drugs.

Reporting of side effects: If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5. Storing Permethrin 5% w/w Cream

Do not store above 25°C. Do not freeze. Keep out of the reach and sight of children. Do not use Permethrin 5% w/w Cream after the date printed after “Exp” on the carton. If the expiry date has passed, take the product back to your pharmacist for safe disposal.

6. Further information

Permethrin 5% w/w Cream is a white cream in a 30 g tube. Active substances: Permethrin (5% w/w)

Other ingredients: Coconut oil, glyceryl monostearate, macrogol cetyl ether, cetomacrogol 1000, isopropyl myristate, lanolin alcohols/liquid paraffin mixture, butylated hydroxytoluene (E321), glycerol, formaldehyde solution, carbomer, sodium hydroxide and purified water.

7. Manufactured in India by:
   TAJ PHARMACEUTICALS LTD.
   Mumbai, India
   Unit No. 214.Old Bake House,
   Maharashtra chambers of Commerce Lane,
   Fort, Mumbai – 400001
   at: Gujarat, INDIA.
   Customer Service and Product Inquiries:
   1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
   Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
   E-mail: tajgroup@tajpharma.com