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Aciclovir 400mg Tablets

Aciclovir 400mg Tablets

Aciclovir

Prescription-only antiviral medicine (POM)
  • MHRA Licensed medicinal product: multiple UK marketing authorisations exist for Aciclovir Tablets BP 400mg, including PL 0142/0402 (Accord UK Ltd) and other generic licences listed in the MHRA products database.
  • Classified as a Prescription Only Medicine (POM) in the United Kingdom.
  • Pharmacotherapeutic classification: direct acting antivirals, nucleosides and nucleotides excluding reverse transcriptase inhibitors; ATC code J05AB01, as stated in approved SmPCs.
  • Product information (SmPC and PIL) approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and published via official databases (e.g. medicines.org.uk/emc, MHRA products database and manufacturer product sites such as Accord).
Systemic antiviral; nucleoside analogue; oral tablet

Description

Aciclovir 400 mg is an oral antiviral medicine used to treat and prevent infections caused by herpes viruses. It is indicated for herpes simplex virus infections of the skin and mucous membranes (including initial and recurrent genital herpes), for suppression of recurrent herpes simplex infections in immunocompetent patients, for prophylaxis of herpes simplex infections in immunocompromised patients, and for the treatment of varicella (chickenpox) and herpes zoster (shingles), according to UK SmPCs for Aciclovir 400 mg Tablets. Aciclovir is a synthetic purine nucleoside analogue that inhibits viral DNA polymerase and viral DNA replication, thereby reducing viral multiplication, shortening outbreaks and lessening symptom severity. The 400 mg strength is commonly used in treatment and suppressive regimens as directed by a prescriber. It does not eradicate latent virus or cure herpes infections; dosing must follow the prescribing clinician’s instructions and the official SmPC/PIL.

Bnefits

  • Antiviral treatment of herpes simplex virus infections of the skin and mucous membranes, including initial and recurrent genital herpes.
  • Suppressive (preventive) therapy for recurrent herpes simplex infections in immunocompetent patients.
  • Prophylaxis of herpes simplex infections in immunocompromised patients.
  • Treatment of varicella (chickenpox) and herpes zoster (shingles) infections as described in UK SmPCs for Aciclovir 400 mg Tablets.
  • Reduces severity and duration of herpes outbreaks and helps relieve symptoms such as pain, itching and lesions.
  • Oral tablet formulation suitable for use in community and outpatient settings under medical supervision.
  • Well-characterised safety and pharmacokinetic profile from long-standing clinical use with established regulatory documentation.

Indications

  • Treatment of herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes (excluding neonatal HSV and severe HSV infections in immunocompromised children).
  • Suppression (prevention of recurrences) of recurrent herpes simplex infections in immunocompetent patients.
  • Prophylaxis of herpes simplex infections in immunocompromised patients.
  • Treatment of varicella (chickenpox) infection.
  • Treatment of herpes zoster (shingles) infection.

Composition

  • Active ingredient: Each tablet contains 400 mg aciclovir (Aciclovir Tablets BP 400mg), a synthetic purine nucleoside analogue antiviral.
  • Selected UK SmPCs for Aciclovir 400 mg Tablets (e.g. PL 0142/0402, Accord-UK Ltd) list excipients such as lactose monohydrate, povidone, maize starch, sodium starch glycolate, colloidal anhydrous silica and magnesium stearate (exact excipient profile may vary between licensed manufacturers).
  • Different MHRA-licensed generic Aciclovir 400 mg tablet products may have excipient variations; the specific excipient profile for the pack supplied by Aestheticsrx Pharma is not stated by the seller and must be checked on the physical pack and corresponding PIL.

Formulation

  • Pharmaceutical form: Tablet for oral use.
  • According to UK SmPCs, Aciclovir 400 mg Tablets are described as solid oral tablets containing 400 mg aciclovir per tablet; appearance (shape, colour, debossing) may vary between generic manufacturers (e.g. pink uncoated tablets or white to off-white tablets with product-specific markings).
  • Pharmacotherapeutic group: Direct acting antivirals, nucleosides and nucleotides excluding reverse transcriptase inhibitors; ATC code J05AB01.

Packaging

  • Pack size supplied by the seller: 56 tablets (Aciclovir 400mg (56 tablets)).
  • UK SmPCs for Aciclovir 400 mg Tablets describe blister packs comprising PVC/PVdC or similar film with aluminium foil lidding, with typical marketed pack sizes including 56 tablets (and other sizes depending on the manufacturer).
  • Exact blister style, carton artwork and branding for the pack supplied by Aestheticsrx Pharma are not specified on the product page and should be confirmed from the physical packaging.

Usage

  • Use only under the supervision of a suitably qualified prescriber; dosing must follow the individual prescription and the official product literature (SmPC/PIL) for the specific Aciclovir 400 mg tablet product supplied.
  • For treatment of herpes simplex infections in adults, UK SmPCs typically describe oral aciclovir regimens based on 200 mg taken five times daily for 5 days (with possible extension in severe initial infections). In severely immunocompromised patients or those with impaired absorption, the dose may be increased to 400 mg five times daily or intravenous dosing considered.
  • For suppression of recurrent herpes simplex in immunocompetent adults, SmPCs describe 200 mg aciclovir four times daily or 400 mg twice daily, with possible titration to lower total daily doses depending on clinical response and recurrence pattern.
  • For prophylaxis of herpes simplex in immunocompromised patients, oral regimens of 200 mg four times daily are described; in severely immunocompromised patients or those with impaired absorption, the dose may be increased to 400 mg four times daily or given intravenously.
  • For treatment of varicella (chickenpox) and herpes zoster (shingles) in adults, SmPCs describe oral regimens of 800 mg aciclovir five times daily for 7 days; this may be achieved by taking multiple 400 mg tablets per dose where applicable, in accordance with the prescriber’s instructions.
  • Paediatric dosing, dosing in the elderly and dosing in renal impairment are specifically described in the SmPC and require prescriber assessment; in patients with significant renal impairment, dose adjustments are recommended.
  • Tablets are intended for oral use and may be swallowed whole with water; some SmPCs state that tablets can be dispersed in at least 50 ml of water and the suspension consumed immediately.
  • Patients are advised in PILs to begin treatment as early as possible after symptom onset, complete the full prescribed course, maintain adequate hydration (especially at higher doses) and seek medical advice if symptoms worsen or if serious side effects occur.

Contraindications

  • Hypersensitivity to aciclovir.
  • Hypersensitivity to valaciclovir (the prodrug of aciclovir).
  • Hypersensitivity to any of the excipients listed in the specific Aciclovir 400 mg Tablets SmPC and PIL.
  • Any other contraindications specified in the SmPC for the exact marketed Aciclovir 400 mg tablet product supplied; these must be checked in the current product literature.

Adverse Effects

  • Adverse reactions listed in UK SmPCs for Aciclovir 400 mg Tablets include the following frequency categories (very common, common, uncommon, rare, very rare):
  • Blood and lymphatic system disorders – very rare: anaemia, leukopenia, thrombocytopenia.
  • Immune system disorders – rare: anaphylaxis.
  • Psychiatric and nervous system disorders – common: headache, dizziness; very rare: agitation, confusion, tremor, ataxia, dysarthria, hallucinations, psychotic symptoms, convulsions, somnolence, encephalopathy and coma (often in patients with renal impairment or other predisposing factors and usually reversible on discontinuation).
  • Respiratory, thoracic and mediastinal disorders – rare: dyspnoea.
  • Gastrointestinal disorders – common: nausea, vomiting, diarrhoea, abdominal pain.
  • Hepato-biliary disorders – rare: reversible increases in bilirubin and liver-related enzymes; very rare: hepatitis, jaundice.
  • Skin and subcutaneous tissue disorders – common: pruritus, rashes (including photosensitivity); uncommon: urticaria, diffuse hair loss (causality with aciclovir uncertain); rare: angioedema.
  • Renal and urinary disorders – rare: increases in blood urea and creatinine; very rare: acute renal failure, renal pain (which may be associated with renal failure and crystalluria).
  • General disorders and administration site conditions – common: fatigue, fever.
  • Overdose information from SmPCs notes that large single ingested doses (up to 20 g) have usually not caused serious toxicity; repeated overdoses may be associated with gastrointestinal and neurological symptoms. In significant overdose, monitoring and consideration of haemodialysis to enhance elimination may be required.

Storage Conditions

  • UK SmPCs for Aciclovir 400 mg Tablets (e.g. Accord-UK Ltd PL 0142/0402) state that no special storage conditions are required for this product.
  • Shelf life for specific generic products is commonly 3 years (check the specific SmPC/PIL and packaging for the product supplied).
  • Tablets should be stored in the original blister and carton as supplied, with protection as indicated on the pack labelling.
  • As with all prescription medicines, the product should be kept out of the sight and reach of children.

Duration

According to UK SmPCs and PILs for Aciclovir Tablets, typical treatment durations include approximately 5 days (or longer if clinically indicated) for treatment of herpes simplex infections; around 7 days for treatment of varicella (chickenpox) and herpes zoster (shingles); prophylaxis in immunocompromised patients continues for the duration of the period at risk; and suppression of recurrent herpes simplex infections in immunocompetent patients may be continued long term but should be reviewed periodically, with recommendations to interrupt therapy at intervals of 6\u201312 months to reassess the natural history of the disease. Actual duration must follow the prescriber\u2019s directions.

Onset

Not publicly listed (no specific, quantified onset-of-action time is stated in the referenced SmPCs or patient leaflets for Aciclovir 400 mg Tablets).

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