Nitrostat

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• NITROSTAT DESCRIPTION
• CLINICAL PHARMACOLOGY
• INDICATIONS & USAGE
• NITROSTAT CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• INFORMATION FOR PATIENTS
• DRUG INTERACTIONS
• DRUG & OR LABORATORY TEST INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• NURSING MOTHERS
• PEDIATRIC USE
• GERIATRIC USE
• NITROSTAT ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• STORAGE AND HANDLING
• INFORMATION FOR PATIENTS
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

NITROSTAT DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS & USAGE

NITROSTAT CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

INFORMATION FOR PATIENTS

DRUG INTERACTIONS

DRUG & OR LABORATORY TEST INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

NITROSTAT ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

STORAGE AND HANDLING

INFORMATION FOR PATIENTS

• ●     very recent heart attack

• ●     severe anemia

• ●     increased pressure in the head

• ●     You are taking any medicines that are used to treat angina, heart failure, or an irregular heartbeat.

• ●     You are taking any medicines that reduce blood pressure.

• ●     You are taking any diuretics (water pills).

• ●     You are taking medications to treat depression or psychiatric illness.

• ●     You are taking ergotamine or similar drugs for migraine headaches.

• ●     You are taking aspirin.

• ●     You are taking the blood thinner medicine heparin.

• ●     You are taking any medicines for erectile dysfunction.

• ●     You are pregnant or plan to become pregnant.

• ●     You are breastfeeding.

• ●     Do not chew, crush, or swallow NITROSTAT tablets.

• ●     You should sit down when taking NITROSTAT tablets and use caution when you stand up. This eliminates the possibility of falling due to lightheadedness or dizziness.

• ●     One tablet should be dissolved under the tongue or in the oral cavity at the first sign of chest pain.

• ●     The dose may be repeated approximately every 5 minutes, until the chest pain is relieved.

• ●     If the pain persists after a total of 3 tablets in a 15-minute period, or is different than you typically experience, call your doctor or seek emergency help.

• ●     NITROSTAT may be used 5 to 10 minutes prior to activities that might cause chest pain.

• ●     You may feel a burning or tingling sensation in your mouth when you take NITROSTAT.

• ●     Do not breastfeed. It is not known if NITROSTAT will pass through your milk.

• ●     Do not consume alcohol while taking NITROSTAT, as this can lower your blood pressure.

• ●     Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.

• ●     headache

• ●     vertigo (a major symptom of balance disorder)

• ●     dizziness

• ●     weakness

• ●     heart palpitations (unusual awareness of the heartbeat)

• ●     low blood pressure upon rising from a seated position

• ●     nausea and vomiting

• ●     sweating

• ●     paleness

• ●     fainting

• ●     flushing (warm or red condition of your skin)

• ●     other skin reactions that may be severe

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION