Hivid (Tablets) Instructions for Use

Marketing Authorization Holder

F. Hoffmann-La Roche, Ltd (Switzerland)

Manufactured By

Hoffmann-La Roche, Inc. (USA)

ATC Code

J05AF03 (Zalcitabine)

Active Substance

Zalcitabine (Rec.INN registered by WHO)

Dosage Form

Hivid

Film-coated tablets, 375 mcg: 100 pcs.

Dosage Form, Packaging, and Composition

100 pcs. – dark glass bottles (1) – cardboard packs.
20 pcs. – blister packs (5) – cardboard packs.

Clinical-Pharmacological Group

Antiviral drug active against HIV

Pharmacotherapeutic Group

Antiviral [HIV] agent

Pharmacological Action

Antiviral agent, a group of reverse transcriptase inhibitors. Zalcitabine is a synthetic analogue of the natural nucleoside 2-deoxycytidine. It is active against HIV.

In the cells of the macroorganism, under the influence of enzymes, Zalcitabine is converted into an active metabolite – Zalcitabine triphosphate, which, by blocking viral reverse transcriptase, disrupts their replication by inhibiting the synthesis of viral DNA.

In vitro studies have shown that Zalcitabine has approximately the same effect on HIV-1 and HIV-2. Zalcitabine exhibits synergy with other antiviral agents, especially with zidovudine and interferon alpha.

Indications

Treatment of AIDS in adults in cases of intolerance or insufficient efficacy of zidovudine. In combination with zidovudine for the therapy of HIV infection.

ICD codes

Dosage Regimen

Administer orally with or without food.

For monotherapy in adults, the dose is 750 mcg every 8 hours (three times daily).

For combination therapy with zidovudine, the dose is 750 mcg three times daily co-administered with 200 mg of zidovudine.

Do not exceed the total daily dose of 2.25 mg.

In patients with renal impairment, adjust the dosing interval based on creatinine clearance.

For creatinine clearance 10-40 mL/min, administer 750 mcg every 12 hours.

For creatinine clearance less than 10 mL/min, administer a single 750 mcg dose.

Immediately discontinue treatment if signs of peripheral neuropathy develop.

Monitor patients for oral ulcers and pancreatitis; discontinue use if these occur.

Adverse Reactions

Nervous system disorders very common – peripheral neuropathy. Initially, sensations of numbness and paresthesia in the extremities appear; if Zalcitabine is not discontinued, severe pain occurs – constant or shooting in nature; if administration continues, neuropathy becomes irreversible; upon discontinuation of zalcitabine, slow regression of neuropathy occurs. Common – headache, dizziness; rare – tremor, dyskinesia, ataxia, seizures, amnesia, drowsiness, insomnia, depression, agitation, vision, hearing, taste disorders.

Digestive system disorders common – ulcerative lesions of the oral mucosa, nausea, vomiting, dysphagia, anorexia, abdominal pain, diarrhea, constipation; rare – dry oral mucosa, stomatitis, esophageal ulcers, glossitis, rectal bleeding, rectal mucosal ulcers, pancreatitis, hepatitis.

Hematopoietic system disorders common – anemia, leukopenia, thrombocytopenia.

Cardiovascular system disorders common – chest pain; rare – arterial hypertension, tachycardia, cardiomyopathy.

Dermatological reactions common – itching, skin rash; rare – dermatitis, alopecia.

Other common – myalgia, arthralgia, sweating, weight loss, fever, weakness; rare – pharyngitis, renal function disorders.

Contraindications

Hypersensitivity to zalcitabine.

Use in Hepatic Impairment

Use with caution in patients with impaired liver function.

Use in Renal Impairment

Use with caution in patients with impaired renal function.

Geriatric Use

Should be prescribed with caution to elderly patients to avoid worsening of concomitant diseases.

Special Precautions

Use with caution in patients with a history of pancreatitis or having risk factors for its development, with elevated plasma alpha-amylase levels, cardiomyopathy, heart failure, esophageal ulcers, impaired liver and kidney function, with a low CD4 cell count (less than 50/mcL).

Zalcitabine should not be used concurrently with drugs that cause peripheral neuropathy.

Drug Interactions

The risk of zalcitabine side effects is increased by aminoglycosides, amphotericin, foscarnet.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.