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Rx Item-Sumatriptan 5Mg Nasal Spray 6 By Lannett Pharma

NDC 00781-6524-86 UPC/GTIN No.3-07816-52486-8 Mfg.Part No.652486BRAND: SUMATRIPTAN NDC: 00527-1818-43,527181843 UPC: 3-07816-52486-8,307816524868 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Sumatriptan 5Mg Nasal Spray 6 By Lannett Pharma

$487.95$413.51

Item No.: RX567425 NDC No.527181843 UPC No.:307816524868 NDC No. 00527-1818-43 UPC/GTIN No. MPN 181843 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx567425 Sumatriptan 5mg Spy 6 by Lannett Pharma Item No. 567425 NDC No. 00527181843 UPC No. Other Name Imitrex,Sumatriptan Therapeutic Code 283228

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IMITREX- sumatriptan succinate tablet
HIGHLIGHTS OF PRESCRIBING INFORMATION


These highlights do not include all the information needed to use SUMATRIPTAN TABLETS safely and effectively. See full prescribing information for SUMATRIPTAN TABLETS.
SUMATRIPTAN tablets, for oral use
Initial U.S. Approval: 1992

INDICATIONS AND USAGE

Sumatriptan tablets, USP are a serotonin (5-HT1B/1D) receptor agonist (triptan) indicated for acute treatment of migraine with or without aura in adults. (1)
Limitations of Use:

Use only if a clear diagnosis of migraine headache has been established. (1)
Not indicated for the prophylactic therapy of migraine attacks. (1)
Not indicated for the treatment of cluster headache. (1)

DOSAGE AND ADMINISTRATION

Single dose of 25 mg, 50 mg, or 100 mg tablet.(2.1)
A second dose should only be considered if some response to the first dose was observed. Separate doses by at least 2 hours. (2.1)
Maximum dose in a 24-hour period: 200 mg. (2.1)
Maximum single dose should not exceed 50 mg in patients with mild to moderate hepatic impairment. (2.2)

DOSAGE FORMS AND STRENGTHS

Tablets: 25 mg, 50 mg, and 100 mg (3)

CONTRAINDICATIONS

History of coronary artery disease or coronary artery vasospasm (4)
Wolff-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders (4)
History of stroke, transient ischemic attack, or hemiplegic or basilar migraine (4)
Peripheral vascular disease (4)
Ischemic bowel disease (4)
Uncontrolled hypertension (4)
Recent (within 24 hours) use of another 5-HT1 agonist (e.g., another triptan) or of an ergotamine-containing medication. (4)
Concurrent or recent (past 2 weeks) use of monoamine oxidase-A inhibitor. (4)
Hypersensitivity to sumatriptan tablets (angioedema and anaphylaxis seen). (4)
Severe hepatic impairment. (4)

WARNINGS AND PRECAUTIONS

Myocardial ischemia/infarction and Prinzmetal's angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors. (5.1)
Arrhythmias: Discontinue sumatriptan if occurs. (5.2)
Chest/throat/neck/jaw pain, tightness, pressure, or heaviness: Generally not associated with myocardial ischemia; evaluate for coronary artery disease in patients at high risk. (5.3)
Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue sumatriptan if occurs. (5.4)
Gastrointestinal ischemic reactions and peripheral vasospastic reactions: Discontinue sumatriptan if occurs. (5.5)
Medication overuse headache: Detoxification may be necessary. (5.6)
Serotonin syndrome: Discontinue sumatriptan if occurs. (5.7)
Seizures: Use with caution in patients with epilepsy or a lowered seizure threshold. (5.10)

ADVERSE REACTIONS

Most common adverse reactions (?2% and >placebo) were paresthesia, warm/cold sensation, chest pain/tightness/pressure and/or heaviness, neck/throat/jaw pain/tightness/pressure, other sensations of pain/pressure/tightness/heaviness, vertigo, and malaise/fatigue. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on animal data, may cause fetal harm. (8.1)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
INDICATIONS AND USAGE

Sumatriptan tablets, USP 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 tablets, USP, reconsider the diagnosis of migraine before sumatriptan tablets, USP are administered to treat any subsequent attacks.
Sumatriptan tablets, USP are not indicated for the prevention of migraine attacks.
Safety and effectiveness of sumatriptan tablets, USP have not been established for cluster headache.
DOSAGE AND ADMINISTRATION

2.1 Dosing Information

The recommended dose of sumatriptan 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 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 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)].
DESCRIPTION

Sumatriptan tablets, USP 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),
The molecular formula is C14H21N3O2S�C4H6O4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline.
Each sumatriptan tablet, USP 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 croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, polysorbate 80, and sodium bicarbonate.
CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Sumatriptan binds with high affinity to human cloned 5-HT1B/1D receptors. Sumatriptan presumably exerts its therapeutic effects in the treatment of migraine headache through agonist effects at the 5-HT1B/1D receptors on intracranial blood vessels and sensory nerves of the trigeminal system, which result in cranial vessel constriction and inhibition of pro-inflammatory neuropeptide release.

NDC 00781-6524-86 UPC/GTIN No.3-07816-52486-8 Mfg.Part No.652486
RX ITEM-Sumatriptan 5Mg Nasal Spray 6 By
NDC 00781-6524-86 UPC/GTIN No.3-07816-52486-8 Mfg.Part No.652486

BRAND: SUMATRIPTAN NDC: 00527-1818-43,527181843 UPC: 3-07816-52486-8,307816524868
Sumatriptan 5Mg Nasal Spray 6 By Lannett
BRAND: SUMATRIPTAN NDC: 00527-1818-43,527181843 UPC: 3-07816-52486-8,307816524868

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
Click above for Imitrex
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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