PROPRANOLOL HYDROCHLORIDE tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ)

Saatavilla:

Dispensing Solutions, Inc.

INN (Kansainvälinen yleisnimi):

PROPRANOLOL HYDROCHLORIDE

Koostumus:

PROPRANOLOL 20 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus bradycardia and greater than first degree block; 3) bronchial asthma; and 4) in patients with known hypersensitivity to propranolol hydrochloride.

Tuoteyhteenveto:

Propranolol hydrochloride tablets, USP are supplied as follows: 10mg : Each tablet is an orange colored, round, biconvex tablet, embossed with "P" and "10" on either side of the breakline on one side and plain on the other side. Each 10 mg tablet contains 10 mg propranolol hydrochloride USP and is supplied in the following packages sizes: Bottles of 30 tablets                                 NDC 23155-110-03 Bottles of 60 tablets                                  NDC 23155-110-06 Bottles of 100 tablets                                 NDC 23155-110-01 Bottles of 500 tablets                                  NDC 23155-110-05 Bottles of 1000 tablets                                 NDC 23155-110-10 20mg : Each tablet is a blue colored, round, biconvex tablet, embossed with "P" and "20" on either side of the breakline on one side and plain on the other side. Each 20 mg tablet contains 20 mg of propranolol hydrochloride USP and is supplied in the following package sizes: Bottles of 30 tablets                                 NDC 23155-111-03 Bottles of 60 tablets                                  NDC 23155-111-06 Bottles of 100 tablets                                  NDC 23155-111-01 Bottles of 500 tablets                                  NDC 23155-111-05 Bottles of 1000 tablets                                 NDC 23155-111-10 40mg : Each tablet is a green colored, round, biconvex tablet, embossed with "P" and "40"on either side of the breakline on one side and plain on the other side. Each 40 mg tablet contains 40 mg of propranolol hydrochloride USP and is supplied in the following package sizes: Bottles of 30 tablets                                 NDC 23155-112-03 Bottles of 60 tablets                                  NDC 23155-112-06 Bottles of 100 tablets                                 NDC 23155-112-01 Bottles of 500 tablets                                  NDC 23155-112-05 Bottles of 1000 tablets                                 NDC 23155-112-10 60mg : Each tablet is a pink colored, round, biconvex tablet, embossed with "P" and "60" on either side of the breakline on one side and plain on the other side. Each 60 mg tablet contains 60 mg of propranolol hydrochloride USP and is supplied in the following package sizes: Bottles of 30 tablets                                 NDC 23155-113-03 Bottles of 60 tablets                                  NDC 23155-113-06 Bottles of 100 tablets                                 NDC 23155-113-01 Bottles of 500 tablets                                  NDC 23155-113-05 Bottles of 1000 tablets                                 NDC 23155-113-10 80mg : Each tablet is a yellow colored, round, biconvex tablet, embossed with "P" and "80" on either side of the breakline on one side and plain on the other side. Each 80 mg tablet contains 80 mg of propranolol hydrochloride USP and is supplied in the following package sizes: Bottles of 30 tablets                                 NDC 23155-114-03 Bottles of 60 tablets                                  NDC 23155-114-06 Bottles of 100 tablets                                 NDC 23155-114-01 Bottles of 500 tablets                                  NDC 23155-114-05 Bottles of 1000 tablets                                 NDC 23155-114-10 Storage: Store at 20°-25 °C (68 -(°77 (°F); excursions permitted to 15°-30 (°C (59(°-86 (°F) [see USP Controlled Room Temperature] Protect from light. Dispense in a well closed, light-resistant container as defined in USP. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

PROPRANOLOL HYDROCHLORIDE - PROPRANOLOL HYDROCHLORIDE TABLET
DISPENSING SOLUTIONS, INC.
----------
PROPRANOLOL HYDROCHLORIDE TABLETS, USP
RX ONLY
DESCRIPTION
hydrochloride(Propranolol is a synthetic beta-adrenergic receptor
blocking agent chemically
described as 2-Propanol,
1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy)-, hydrochloride,(±)-.
It’s
molecular and structural formulae are:
Propranolol hydrochloride is a stable, white, crystalline solid which
is readily soluble in water and in
ethanol. Its molecular weight is 295.80.
Propranolol hydrochloride tablets, USP are available as 10 mg, 20 mg,
40 mg, 60 mg, and 80 mg tablets
for oral administration.
The inactive ingredients contained in propranolol hydrochloride
tablets, USP are: lactose monohydrate,
corn starch, sodium starch glycolate, magnesium stearate, and
povidone. In addition, propranolol
hydrochloride tablets, USP 10 mg, 40 mg and 80 mg contain and C yellow
No.6 Aluminium Lake and
Color D and C Yellow No. 10; propranolol hydrochloride tablets, USP 20
mg and 40mg contain FD and
C Blue No.1 and propranolol hydrochloride tablets, USP 60 mg contain D
and C Red No. 30 Lake.
CONTRAINDICATIONS
Propranolol is contraindicated in 1) cardiogenic shock; 2) sinus
bradycardia and greater than first
degree block; 3) bronchial asthma; and 4) in patients with known
hypersensitivity to propranolol
hydrochloride.
ADVERSE REACTIONS
The following adverse events were observed and have been reported in
patients using propranolol.
CARDIOVASCULAR: Bradycardia; congestive heart failure; intensification
of AV block; hypotension;
paresthesia of hands; thrombocytopenic purpura; arterial
insufficiency, usually of the Raynaud type.
CENTRAL NERVOUS SYSTEM: Lightheadedness, mental depression manifested
by insomnia, lassitude,
weakness, fatigue; catatonia; visual disturbances; hallucinations;
vivid dreams; an acute reversible
syndrome characterized by disorientation for time and place,
short-term memory loss, emotional lability,
slightly clouded sensorium, and decreased performance