Zovicrem lips 50 Mg/G Cream 2 G Tube

Zovicrem Lips (Acyclovir 50 Mg / G Cream 2 G Tube)

ACTION AND MECHANISM

- Antiviral. Acyclovir is an antiviral agent with virostatic action, with a structure similar to guanosine. It works by inhibiting the cellular synthesis of viral DNA.

Antiviral action is manifested only in viruses in replication phase. This selective action is due to the fact that in its first phosphorylation to acyclovir monophosphate, an enzyme specific to the virus, thymidine kinase, intervenes. In cells not infected with the virus, this first phosphorylation is very slow. Subsequent phosphorylations until the active form of the drug, acyclovir triphosphate, is carried out using cellular enzymes. Acyclovir triphosphate is capable of inhibiting viral replication in three ways:

- Selective inhibition of viral DNA polymerase.

- Competition between acyclovir triphosphate with guanosine triphosphate for incorporation into viral DNA.

- Interruption of the chain when incorporated into the viral DNA.

It is especially active against herpes simplex virus (HSV) types 1 and 2, and the varicella Zoster virus; in descending order, it also presents in vitro activity against Epstein-Barr virus (EBV), human herpes virus type 6 (HHV-6) and cytomegalovirus (CMV). Compared to CMV (which does not present thymidine kinase), its activity is much less than that of fanciclovir, foscarnet and vidarabine.

PHARMACOKINETICS

Topical route:

- Absorption: Intact skin: minimal. Acyclovir is not detected in blood or urine. Sick skin (herpes zoster) moderate. Serum concentrations up to 0.28 mcg / ml have been described in patients with normal renal function.

- Elimination: Renal. Up to approximately 9% of the total daily dose can be excreted in the urine.

Pharmacokinetics in special situations :

- Renal impairment: Plasma concentrations of 0.78 mcg / ml have been described in patients with renal impairment.

POSOLOGY

- Adults and children, topic: Apply five times a day every four hours, omitting the application during the hours of sleep at night.

It is important to start the treatment as soon as possible, as soon as the first symptoms of the infection appear, to achieve greater effectiveness of the product. Treatment should be continued for 5 days. If healing has not occurred within 5 days, treatment may continue for an additional 5 days to a total of 10 days.

RULES FOR THE CORRECT ADMINISTRATION

A sufficient amount of product should be applied to cover the affected area with a thin layer. The dose, the frequency of application and the duration of the recommended treatment should not be exceeded.

If possible, use a finger pad or a rubber glove to avoid autoinoculation in other parts of the body. If this is not possible, it is advisable to wash your hands before and after the application of the medication, as well as avoiding as much as possible the rubbing of the lesions with your hands, towels, etc., so that the infection does not worsen or spread even other people.

CONTRAINDICATIONS

- Known hypersensitivity to acyclovir, valacyclovir or any other component of the specialty.

PRECAUTIONS

- Application on mucosa: Except for cold sores, topical application of acyclovir on mucous membranes is not recommended as in the mouth, eye or vagina as it can be irritating. Special care must be taken to avoid accidental introduction into the eye.

- [IMMUNODEFICIENCY]: In severely immunosuppressed patients (eg patients with [HIV INFECTION] or bone marrow transplant recipients), in case of severe disease or frequent recurrences, oral administration of acyclovir should be considered. Such patients should be encouraged to consult a physician regarding the treatment of any infection.

- [GENITAL HERPES]. Women with genital herpes may be more likely to develop cervical cancer; A Pap smear may need to be done annually or more frequently.

EXCIPIENT WARNINGS:

- This medicine contains propylene glycol, so it can cause skin irritation.

EXCIPIENT WARNINGS:

- Because it contains cetostearyl alcohol, it can cause local skin reactions, such as contact dermatitis.

ADVICE TO THE PATIENT

- Avoid contact with the eyes or with the mucosa of the mouth or vagina.

- Administer the medication as soon as possible after the first symptoms appear.

- Do not exceed the dose, the frequency of application or the duration of the recommended treatment.

- If possible, use a finger pad or a rubber glove to avoid infection in other parts of the body. If this is not possible, it is advisable to wash your hands before and after applying the medicine.

SPECIAL WARNINGS

- A Pap smear is recommended at least annually in women with genital herpes.

PREGNANCY

FDA category B.

Safety in animals : they do not indicate direct or indirect harmful effects during pregnancy, embryonic or fetal development, delivery or postnatal development.

Safety in humans : Adequate and well-controlled studies in humans have not been conducted. Data obtained in a limited number of exposed pregnancies indicate that acyclovir does not produce any adverse effect on the health of the fetus or newborn. To date, no other relevant epidemiological data are available. Since human experience is limited, acyclovir should only be considered when the potential benefits outweigh the potential for unknown risks.

LACTATION

The limited human data available demonstrate that the drug passes into breast milk after systemic administration, but after topical administration of acyclovir systemic absorption is minimal.

CHILDREN

There have been no adequate studies on the relationship between age and the effects of topical acyclovir in the pediatric population. However, no specific problems have been described in this age group.

Cold sores are a recurrence of an infection inside the mouth that generally contracts at an early age, therefore it is necessary to make a first medical diagnosis especially in children in whom the symptoms of this first infection may go unnoticed or be confused with disorders of teething or other oral processes.

SENIORS

Although adequate studies have not been conducted on the relationship between age and the effects of topical acyclovir in the geriatric population, no specifically geriatric problems are anticipated in this age group.

ADVERSE REACTIONS

- Allergic / dermatological. It is rare (0.1-1.0%) the appearance of temporary [SKIN IRRITATION], [SKIN DRYNESS], [SKIN SKIN] and [ITCHING]. More rare (<0.1%) is the appearance of [ERITEMA] or [CONTACT DERMATITIS]. Occasionally, [HYPERSENSITIVITY REACTIONS] may appear, with [ANGIOEDEMA].

OVERDOSE

Symptoms : After accidental oral administration of topical acyclovir, no adverse effects are expected.

Treatment : Acyclovir can be removed by dialysis.

Leaflet Zovicrem Lipstick 50 Mg / G Cream 2 G Tube

Technical Data Sheet Zovicrem Lipstick 50 Mg / G Cream 2 G Tube