Pentam

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of pentamidine in the elderly with use in other age groups.

In the U.S.

• Pentam

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antiprotozoal

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

• It is given as a shot into a muscle or as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

All products:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of low calcium levels like muscle cramps or spasms, numbness and tingling, or seizures.
• Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
• A heartbeat that does not feel normal.
• Very bad dizziness or passing out.
• Fever or chills.
• Sore throat.
• Any unexplained bruising or bleeding.
• Feeling very tired or weak.
• Low blood sugar. Signs include anger, shaking, fast heartbeat, confusion, or sweating. Keep hard candies, liquid glucose, or orange juice on hand for low blood sugar.
• This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.

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:

• Not hungry.
• Upset stomach.
• Irritation where the shot is given.

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.

• 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.
• 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.
• 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 Pentam 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 Pentam. 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

Common side effects of Pentam include: increased serum creatinine. Other side effects include: hypoglycemia. See below for a comprehensive list of adverse effects.

Cutaneous leishmaniasis:
CDC recommendation: 2 to 3 mg/kg IM or IV once a day or every second day for 4 to 7 doses

Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis, and cardiac arrhythmias have occurred with IM and IV pentamidine. Therefore, parenteral pentamidine use should be limited to patients with demonstrated Pneumocystis jiroveci (formerly, P carinii) and patients should be closely monitored for signs of serious side effects.

Sudden and severe hypotension has occurred after a single IM or IV dose of pentamidine and is more likely with rapid IV administration. Patients should receive the drug while lying down and blood pressure should be monitored closely during administration and several times thereafter until blood pressure is stable. Equipment for emergency resuscitation should be available.

Extravasations have been reported, progressing to ulceration, tissue necrosis, and/or sloughing at the injection site in some cases. Surgical debridement and skin grafting have been required in a few of these cases and long-term sequelae have been reported. Precautions should be taken to prevent extravasation, including proper positioning of the IV needle or catheter and close observation during administration. The pentamidine injection should be stopped immediately if extravasation occurs and restarted in another vein. The extravasation should be managed symptomatically.

Cautious use is recommended in patients with hypertension, hypotension, ventricular tachycardia, hypoglycemia, hyperglycemia, hypocalcemia, pancreatitis, leukopenia, thrombocytopenia, anemia, and Stevens-Johnson syndrome.

Pentamidine has induced hypoglycemia associated with pancreatic islet cell necrosis and high plasma insulin concentrations. Hyperglycemia and diabetes mellitus (with or without preceding hypoglycemia) have been reported, sometimes several months after pentamidine treatment. Blood glucose concentrations should be monitored daily during pentamidine treatment and several times thereafter.

Before, during, and after therapy with pentamidine, monitoring of blood urea nitrogen (BUN), serum creatinine, blood glucose, complete blood count, platelet count, liver function tests (including serum bilirubin, alkaline phosphatase, AST, and ALT), serum calcium, and electrocardiogram is recommended. Serum creatinine, BUN, and blood glucose should be checked daily.

Concomitant or sequential administration of other nephrotoxic drugs should be avoided if possible, or closely monitored.

Patients receiving inhaled pentamidine prophylaxis may still be at risk of developing acute Pneumocystis pneumonia (PCP). Patients with symptoms of a pulmonary infection should be thoroughly evaluated for PCP and other infections. Pentamidine use may result in atypical presentation of PCP, including altered radiographic results and clinical features. The presence of PCP should be excluded in symptomatic patients before initiating prophylaxis. The dose of nebulized pentamidine is insufficient for the treatment of PCP. Extrapulmonary pneumocystosis has been reported and should be considered when evaluating patients with unexplained symptoms.

The extent and consequence of pentamidine accumulation after inhalation is unknown. Patients should be monitored closely for the development of adverse reactions, as with parenteral pentamidine.

Inhaled pentamidine has been associated with acute pancreatitis and should be discontinued if signs or symptoms of pancreatitis occur.

Safety and efficacy of parenteral pentamidine have not been established in pediatric patients less than 5 months of age. Safety and efficacy of nebulized pentamidine have not been established in pediatric patients less than 17 years of age.

Parenteral pentamidine should be administered via IV infusion over 60 to 120 minutes or via deep IM injection.

Pentamidine for oral inhalation should be administered via the Respirgard(R) II nebulizer following reconstitution (one vial [300 mg] dissolved in 6 mL sterile water for injection). The dose should be delivered until the nebulizer chamber is empty (about 30 to 45 minutes). Pentamidine for oral inhalation should not be mixed with other drugs. The Respirgard(R) II nebulizer should not be used to administer bronchodilators.

Some patients, especially those with a history of smoking or asthma, may experience bronchospasm or cough with inhaled pentamidine. Pretreatment with an inhaled bronchodilator may minimize this reaction.