GNH USA

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.

Codeine Phosphate Sesquihydrate

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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?+
Histaverin contains codeine phosphate sesquihydrate as its active pharmaceutical ingredient.
Is Histaverin available over the counter in the EU?+
The regulatory status of Histaverin varies by country; it is generally prescription‑only, but local regulations should be consulted.
What conditions is Histaverin commonly prescribed for?+
Histaverin is commonly used to treat mild to moderate pain and to suppress cough associated with upper respiratory infections.
How does codeine phosphate sesquihydrate relieve pain?+
It acts as an agonist at μ‑opioid receptors in the central nervous system, reducing the perception of pain.
Can Histaverin be taken with alcohol?+
Combining Histaverin with alcohol can increase sedation and respiratory depression, so it should be avoided or used only under medical supervision.
What are the most common side effects of Histaverin?+
Common side effects include nausea, constipation, and mild drowsiness.
Is there a risk of dependence with Histaverin?+
Yes, prolonged use of codeine‑containing products can lead to physical dependence and withdrawal symptoms.
Should Histaverin be used during pregnancy?+
Pregnant or breastfeeding women should only use Histaverin if advised by a healthcare professional, as safety data are limited.
How should Histaverin be stored?+
Store Histaverin at room temperature, away from moisture and heat, and keep it out of reach of children.
What should I do if I miss a dose of Histaverin?+
If a dose is missed, take it as soon as remembered unless it is close to the time of the next scheduled dose; do not double‑dose.
Can Histaverin interact with antidepressants?+
Certain antidepressants, especially those that affect CNS activity, may increase sedation when taken with Histaverin and should be used with caution.
What is the legal classification of codeine in the EU?+
Codeine is generally classified as a controlled substance and is subject to prescription‑only regulations in most EU member states.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Codeine Phosphate Sesquihydrate
Route
Oral Use
Manufacturer
Laboratorio Estedi, S.L.
Origin
EU

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