Zovirax (Acyclovir) Cream 5% 2 g

Active Ingredient: 1 g cream each; 50 mg (5% w / w) acyclovir.

Substituents: Propylene glycol See 6.1 for other adjuncts

3. PHARMACEUTICAL FORM Cream Mixible with water, with propylene glycol containing dimethicone

4. CLINICAL CHARACTERISTICS

4.1. Therapeutic indications ZOVIRAX is indicated for the treatment of Herpes simplex skin infections including the first and recurrent genital herpes and herpes labialis.

4.2. Posology and method

of application Pozology / application frequency and duration: ZOVIRAX should be administered at intervals of about 4 hours by skipping doses 5 times a day, nightly. ZOVIRAX should be applied to the lesions as soon as possible, preferably in the first signs (erythema or prodrome) to the lesions expected to be delivered to the lesions or after the onset of the infection. The treatment can also be started later (papules or blisters). Treatment should be continued for at least 4 days for herpes labialis and at least 5 days for genital herpes. If there is no recovery, the treatment can be continued for a total of 10 days (5 + 5).

Application type: Used externally.

Additional information on special populations: No data available.

Pediatric population: No data available.

Geriatric population: No data.

4.3. Contraindications Acyclovir is contraindicated in patients with known hypersensitivity to any substance, including valaciclovir, propylene glycol or crescents.

4.4. Special warnings and precautions for use Acyclovir cream is not recommended as it may be irritating to apply to mucous areas such as the mouth, eyes or vagina. Particular care should be taken not to accidentally enter the eye.

Oral acyclovir doses should be considered in patients with severe immune deficiency (eg AIDS patients or bone marrow transplant patients). Such patients should be encouraged to seek medical advice for any infection treatment.

Propylene glycol from adjuvants may cause irritation. Cetostearyl alcohol in ZOVIRAX may cause local skin reactions (eg contact dermatitis).

ZOVIRAX should not be diluted or used as some of the other drugs due to special reasons.

4.5. Interactions with other medicinal products and other forms of interaction Clinically significant interactions have not been identified.

Additional information on special populations No data available.

Pediatric population: No data available.

4.6. Pregnancy and lactation General advice Pregnancy category: B

Women with childbearing potential / Contraception (Contraception) Be cautious when given to women with childbearing potential.

Gestational age The data on the number of cases of pregnancy exposure in limited numbers do not indicate that acyclovir has adverse effects on pregnancy or on the health of the fetus / newborn child. No significant epidemiological data have been obtained until today.

Studies on animals do not indicate direct or indirect harmful effects on pregnancy / embryonal / fetal development / birth or postnatal development (see section 5.3).

Pregnancies developed in women who have used any acyclovir formulation after the acyclovir fetus has been documented in pregnancy records. Findings from these records show that there is no increase in the number of birth defects seen in the whole population and in patients who use acyclovir, and no birth defects have shown an unusual feature or coherent pattern to suggest a common cause. The use of acyclovir should be considered only in cases of severe depression of potential risks with unknown potential benefits. In internationally accepted standard tests, systemic administration of acyclovir did not cause teratogenic or embryotoxic effects in mice, rats or rabbits. In a non-standard study of rats, fetal abnormalities were observed, but maternal toxicity followed only high subcutaneous doses. The clinical evidence of these findings is uncertain.

The lactation period The limited data obtained about humans suggests that the mother of the drug has gone sick when it is systemically taken. However, when used in mothers sucking in acyclovir cream, the dosage that the baby will receive will be ignored.

Reproduction ability / Fertility See Clinical Studies

4.7. Effects on vehicle and machine use No data.

8.4. Unwanted effects The frequency classification is as follows:

Very common> 1/10 Common> 1/100 and <1/10 Uncommon> 1.000 and <1/100 Rare> 1 / 10,000 and <1 / 1.000 Very rare <1 / 10.000. Unknown (unpredictable from available data)

. Clinical trial data observed during clinical trials with 3% ophthalmic pomade were used when frequency categories of adverse events were assigned. Due to the nature of the observed adverse effects, it is not possible to calculate precisely these effects depend on the mode of administration and the disease. Spontaneous reporting data is a basis for the frequencies allocated for postmarketing effects.

Skin and subcutaneous tissue disorders Uncommon: Transient burning or stinging, followed by acyclovir cream application,slight dryness and scaling, itching Rare: Erythema, contact dermatitis following application. Sensitivity tests have shown that reactive substances are mostly acyclovir-based very creamy substances.

Immune system disorders Very rare: premature hypersensitivity reactions including angioedema

4.9. Overdose and treatment No adverse effects are expected, even if a whole tube containing 500 mg (cream) or 135 mg (ointment) acyclovir is taken orally. However, repeated oral doses of acyclovir for several days resulted in gastrointestinal (nausea and vomiting) and neurological (headache and confusion) effects. Acyclovir can be removed by hemodialysis.

5. PHARMACOLOGICAL PROPERTIES 5.1. Farm akodina ic properties

ATC code: D06BB03 Pharmacotherapeutic group: Antiviral drugs (topical dermatological)

Effect Their mechanism of acyclovir, herpes simplex (HSV) type I and II and Varicella zoster virus against in vitro highly effective antiviral agent. Reduce toxicity on mammalian host cells. Acyclovir enters the cell with Herpes infection and then phosphorylates to the active compound acyclovir triphosphate. The first step of this process depends on the presence of the thymidine kinase encoded by the virus. Acyclovir triphosphate, a herb specific DNA polymerase, inhibits the progress of viral DNA synthesis without affecting normal cellular events by acting as an inhibitor and substrate.

Pharmacodynamic effects The randomized clinical trials involving 1,385 people with relapsed Herpes labia and two double-blind studies showed a significant reduction in acyclovir cream remediation action time (p <0.02) and pain relief time (p <0.03) compared with placebo cream. Approximately 60% of patients have been treated with early treatment lesions (prodrome or erythema) and 40% with a late lesion (papule or blister).

5.2. Farm acokinetic properties Absorption: Pharmacokinetic studies have shown minimal systemic absorption following external application of acyclovir cream.

Distribution: Data not available.

Biotransformation: No data available.

Elimination: There is no data.

5.3. Preclinical safety data Clinical trials There is no information on the effect of IV infusion or oral formulations on female fertility. In a study of 20 male patients with normal6 months

sperm counts, there was no clinically significant effect on sperm count, motility or morphology after 1 g oral acyclovir application every day for.

Nonclinical information The extensive results of in vivo and in vitro mutagenicity tests have shown that acyclovir has no genetic risk role in man. No long-term studies in rats and rats have shown that they are carcinogenic. Most reversible adverse reactions to all toxicity-related spermatogenesis in rats and dogs have been reported only at high systemic doses of acyclovir. The two-generation study in mice did not reveal any effect of acyclovir taken orally on fertility.

6. PHARMACEUTICAL PROPERTIES 6. 1. List of auxiliary substances Propylene glycol White soft paraffin Ketostearyl alcohol Liquid paraffin Poloxamer 407 Arlacel 165 Sodium lauryl sulphate Dimethicone Pure water

6.2. Incompatibilities have not been reported.

6.3. Shelf life 24 months

6.4. Special precautions for storage should be kept at room temperature below 25 ° C.

6.5. Packing quality and contents 2 g plastic pumped tube

6.6. Disposal of residual materials and other special precautions for human medical products Unused products or waste materials should be disposed of in accordance with the "Medical Waste Control Regulation" and "Packaging and Packaging Waste Control Regulations". The acyclovir cream contains a specially formulated base and should not be used as a base for undiluted or combined with other medicaments.