Deprizine FusePaq

• It is used to treat gastroesophageal reflux disease (GERD; acid reflux).
• It is used to treat or prevent GI (gastrointestinal) ulcers.
• It is used to treat heartburn and sour stomach.
• It is used to treat syndromes caused by lots of stomach acid.
• It may be given to you for other reasons. Talk with the doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Take at bedtime if you are taking once a day.
• Ask your doctor before you take antacids with Deprizine FusePaq.
• Shake well before use.
• Measure liquid doses carefully. Use the measuring device that comes with this medicine. If there is none, ask the pharmacist for a device to measure Deprizine FusePaq.

What do I do if I miss a dose?

• If you take this medicine on a regular basis, take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Many times Deprizine FusePaq (ranitidine suspension) is taken on an as needed basis. Do not take more often than told by the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Headache.
• Upset stomach or throwing up.
• Hard stools (constipation).
• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store in a refrigerator. Do not freeze.
• Throw away any part not used after 8 weeks.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Deprizine FusePaq or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Deprizine FusePaq. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Using ranitidine may increase your risk of developing pneumonia. Symptoms of pneumonia include chest pain, fever, feeling short of breath, and coughing up green or yellow mucus. Talk with your doctor about your specific risk of developing pneumonia.

Do not use this medication if you are allergic to ranitidine.

Ask a doctor or pharmacist if it is safe for you to take this medicine if you have kidney disease, liver disease, or porphyria.

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

Ranitidine granules and effervescent tablets must be dissolved in water before you take them. Your doctor may recommend an antacid to help relieve pain. Carefully follow your doctor's directions about the type of antacid to use, and when to use it. Avoid drinking alcohol. It can increase the risk of damage to your stomach. It may take up to 8 weeks of using this medicine before your ulcer heals. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 6 weeks of treatment.

Applies to ranitidine: compounding powder, injectable solution, intravenous solution, oral capsule, oral granule effervescent, oral syrup, oral tablet, oral tablet effervescent

General

The most commonly reported side effect for IM administration was injection site pain, and the most commonly reported side effects with IV administration were localized pain and burning.[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Abdominal discomfort/pain, constipation, nausea, vomiting
Very rare (less than 0.01%): Acute pancreatitis, diarrhea[Ref]

Abdominal pain, constipation, and nausea tended to improve with continued treatment.[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Hypotension, chest pain, arrhythmia, bradycardia, atrioventricular block, tachycardia, premature ventricular beats
Very rare (less than 0.01%): Asystole, vasculitis[Ref]

Bradycardia, atrioventricular block, tachycardia, and asystole have occurred in H2 receptor antagonists.[Ref]

Psychiatric

Rare (0.01% to 0.1%): Insomnia, reversible mental confusion, agitation, depression, hallucinations
Frequency not reported: Loss of libido[Ref]

Nervous system

Headache may be related to administration of treatment.[Ref]

Rare (0.01% to 0.1%): Dizziness, somnolence, vertigo, reversible involuntary movement disorders
Very rare (less than 0.01%): Headache/severe headache[Ref]

Dermatologic

Rare (0.01% to 0.1%): Urticaria, angioneurotic edema, skin rash
Very rare (less than 0.01%): Erythema multiforme, alopecia[Ref]

Musculoskeletal

Very rare (less than 0.01%): Musculoskeletal symptoms, arthralgia, myalgia[Ref]

Hepatic

Rare (0.01% to 0.1%): Transient and reversible changes in liver function tests, increased ALT levels
Very rare (less than 0.01%): Hepatocellular/hepatocanalicular/mixed hepatitis with/without jaundice[Ref]

Hepatitis with/without jaundice were usually reversible.

ALT levels increased to at least 2 times the pretreatment levels in patients receiving high IV doses for at least 5 days.[Ref]

Other

Rare (0.01% to 0.1%): Fever, malaise
Frequency not reported: Death[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity reactions
Very rare (less than 0.01%): Anaphylactic shock/anaphylaxis[Ref]

Anaphylactic shock occurred after administration of a single dose.[Ref]

Renal

Rare (0.01% to 0.1%): Elevation in serum creatinine
Very rare (less than 0.01%): Acute interstitial nephritis[Ref]

Elevation in serum creatinine was usually slight, and typically normalized with continued treatment.[Ref]

Respiratory

Rare (0.01% to 0.1%): Bronchospasm
Frequency not reported: Dyspnea, pneumonia[Ref]

Ocular

Rare (0.01% to 0.1%): Reversible blurred vision[Ref]

Hematologic

Very rare (less than 0.01%): Blood count changes, leukopenia, thrombocytopenia, granulocytopenia, agranulocytosis, pancytopenia, marrow hypoplasia/aplasia
Frequency not reported: Aplastic anemia, immune hemolytic anemia/acquired immune hemolytic anemia, eosinophilia[Ref]

Leukopenia, granulocytopenia, and thrombocytopenia were usually reversible.[Ref]

Genitourinary

Very rare (less than 0.01%): Reversible impotence, breast symptoms/conditions, galactorrhea[Ref]

Endocrine

Very rare (less than 0.01%): Gynecomastia[Ref]

Metabolic

Postmarketing reports: Acute porphyria[Ref]

Local

Frequency not reported: Injection site pain, transient localized burning or itching[Ref]

Some side effects of ranitidine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

• Peak effects are reached two to three hours after taking a 150mg dose. Symptomatic relief for GERD occurs within 24 hours after starting therapy with ranitidine.
• One 150mg dose of ranitidine substantially inhibits secretion of gastric acid for approximately 9.5 hours.
• Food does not appear to affect absorption of ranitidine or peak concentrations.

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