Atopalm Clotrimazole Antifungal label

Atopalm Clotrimazole Antifungal

Atopalm Clotrimazole Antifungal Recall

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Uses

Sumatriptan succinate tablets are indicated for the acute treatment of migraine with or without aura in adults.
Limitations of Use:

  • Use only if a clear diagnosis of migraine headache has been established. If a patient has no response to the first migraine attack treated with sumatriptan succinate tablets, reconsider the diagnosis of migraine before sumatriptan succinate tablets are administered to treat any subsequent attacks.
  • Sumatriptan succinate tablets are not indicated for the prevention of migraine attacks.
  • Safety and effectiveness of sumatriptan succinate tablets have not been established for cluster headache.
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History

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Other Information

Sumatriptan succinate tablets contain sumatriptan succinate, a selective 5-HT1B/1D receptor agonist. Sumatriptan succinate is chemically designated as 3-[2-(dimethylamino)ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:

chemical-structure

The molecular formula is C14H21N3O2S·C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan succinate tablet for oral administration contains 35 mg, 70 mg, or 140 mg of sumatriptan succinate, USP equivalent to 25 mg, 50 mg, or 100 mg of sumatriptan, respectively.

Each tablet also contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C Red # 27 aluminum lake (100 mg only), dibasic calcium phosphate, hypromellose, iron oxide red (100 mg only), magnesium stearate, microcrystalline cellulose, polyethylene glycol (25 mg & 50 mg only), polysorbate 80 (25 mg & 50 mg only) propylene glycol (100 mg only), talc and titanium dioxide.

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Atopalm Clotrimazole Antifungal Manufacturers

  • Neopharm Co., Ltd.
    Atopalm Clotrimazole Antifungal | Sun Pharmaceutical Industries Limited
    No Recall

    Atopalm Clotrimazole Antifungal | Sun Pharmaceutical Industries Limited

    Atopalm Clotrimazole Antifungal | Sun Pharmaceutical Industries Limited
    2.1 Dosing Information

    The recommended dose of sumatriptan succinate tablets is 25 mg, 50 mg, or 100 mg. Doses of 50 mg and 100 mg may provide a greater effect than the 25 mg dose, but doses of 100 mg may not provide a greater effect than the 50 mg dose. Higher doses may have a greater risk of adverse reactions [see Clinical Studies (14)].

    If the migraine has not resolved by 2 hours after taking sumatriptan succinate tablets, or returns after a transient improvement, a second dose may be administered at least 2 hours after the first dose. The maximum daily dose is 200 mg in a 24-hour period.

    Use after sumatriptan injection: If the migraine returns following an initial treatment with sumatriptan injection, additional single sumatriptan succinate tablets (up to 100 mg/day) may be given with an interval of at least 2 hours between tablet doses.

    The safety of treating an average of more than 4 headaches in a 30-day period has not been established.

    2.2 Dosing in Patients With Hepatic Impairment

    If treatment is deemed advisable in the presence of mild to moderate hepatic impairment, the maximum single dose should not exceed 50 mg [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

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