Europe — EMA
Histaverin
Histaverin contains codeine phosphate sesquihydrate, an oral opioid analgesic used for mild to moderate pain and cough relief. Learn its uses, effects, and safety.
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What is Codeine Phosphate Sesquihydrate?
Histaverin is an oral medication that contains the opioid analgesic codeine phosphate sesquihydrate as its active ingredient. The product is marketed in the European Union and is supplied in tablet or liquid form, though specific strength information is not disclosed. Codeine phosphate sesquihydrate belongs to the class of opioid analgesics and is used for its pain‑relieving and cough‑suppressing properties. It is intended for short‑term use under medical supervision.
What is Codeine Phosphate Sesquihydrate used for?
Histaverin is indicated for the symptomatic relief of conditions where mild to moderate pain or cough suppression is required.
- Mild to moderate acute pain such as dental, musculoskeletal, or postoperative discomfort. - Cough associated with upper respiratory tract infections when a central antitussive effect is desired. - Pain relief in patients who may not tolerate non‑opioid analgesics. - Adjunct therapy for short‑term management of pain in palliative care settings. - Temporary relief of headache or migraine symptoms when other treatments are insufficient. - Management of discomfort related to minor injuries such as sprains or strains.
What are the side effects of Codeine Phosphate Sesquihydrate?
Like other opioid‑containing medicines, Histaverin may cause a range of adverse reactions, most of which are dose‑related and reversible. These effects are generally mild at therapeutic doses, but they can become more pronounced if the medication is taken in excess or combined with other central nervous system depressants. Patients should report any unexpected or severe symptoms to a healthcare professional promptly. In rare cases, the drug may cause visual disturbances or urinary retention.
Common: - Nausea or vomiting. - Constipation. - Drowsiness or mild sedation.
Serious: - Respiratory depression, particularly at high doses. - Severe allergic reactions (rash, itching, swelling). - Dependence or withdrawal symptoms with prolonged use.
What precautions apply to Codeine Phosphate Sesquihydrate?
When using Histaverin, certain precautions should be observed to minimize risks and ensure safe therapy.
- Assess patient history for respiratory disorders, such as asthma or chronic obstructive pulmonary disease. - Avoid use in individuals with known hypersensitivity to codeine or other opioids. - Use caution in patients with hepatic or renal impairment, as metabolism and excretion may be altered. - Do not combine with other central nervous system depressants, including alcohol, benzodiazepines, or antihistamines, without medical guidance. - Monitor for signs of dependence, especially during prolonged therapy. - Pregnant or breastfeeding women should only use under strict medical supervision.
What does Codeine Phosphate Sesquihydrate interact with?
Histaverin can interact with several medicines, potentially altering its effects or increasing the risk of adverse reactions.
Avoid: - Concomitant use with other opioid analgesics or strong central nervous system depressants (e.g., benzodiazepines, barbiturates, alcohol). - Monoamine oxidase inhibitors (MAOIs) taken within 14 days, due to risk of severe respiratory depression. - CYP2D6 inhibitors (e.g., fluoxetine, paroxetine) that may increase codeine plasma levels.
Use with caution: - Sedating antihistamines or antipsychotics, which may enhance drowsiness. - CNS‑active antidepressants (e.g., tricyclics) that could increase sedation. - Medications that affect hepatic metabolism (e.g., rifampin) may reduce efficacy. - Drugs that prolong QT interval, such as certain antiarrhythmics, should be used cautiously.
Frequently asked questions
What is the active ingredient in Histaverin?+
Is Histaverin available over the counter in the EU?+
What conditions is Histaverin commonly prescribed for?+
How does codeine phosphate sesquihydrate relieve pain?+
Can Histaverin be taken with alcohol?+
What are the most common side effects of Histaverin?+
Is there a risk of dependence with Histaverin?+
Should Histaverin be used during pregnancy?+
How should Histaverin be stored?+
What should I do if I miss a dose of Histaverin?+
Can Histaverin interact with antidepressants?+
What is the legal classification of codeine in the EU?+
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