Promide

Parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations.

Edema: Promide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Promide is particularly useful when an agent with greater diuretic potential is desired.

Promide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of Promide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema.

If gastrointestinal absorption is impaired or oral medication is not practical for any reason, Promide is indicated by the intravenous or intramuscular route.

Parenteral use should be replaced with oral Promide as soon as practical.

Promide belongs to a group of medicines called loop diuretics (also known as water pills). Promide is given to help treat fluid retention (edema) and swelling that is caused by congestive heart failure, liver disease, kidney disease, or other medical conditions. It works by acting on the kidneys to increase the flow of urine.

Promide is also used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Promide is available only with your doctor's prescription.

Edema

Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response.

Adults

The usual initial dose of Promide is 20 to 80 mg given as a single dose. Ordinarily a prompt diuresis ensues. If needed, the same dose can be administered 6 to 8 hours later or the dose may be increased. The dose may be raised by 20 or 40 mg and given not sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained. The individually determined single dose should then be given once or twice daily (eg, at 8 am and 2 pm). The dose of Promide may be carefully titrated up to 600 mg/day in patients with clinically severe edematous states.

Edema may be most efficiently and safely mobilized by giving Promide on 2 to 4 consecutive days each week.

When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable.

Geriatric patients

In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range.

Pediatric patients

The usual initial dose of oral Promide in pediatric patients is 2 mg/kg body weight, given as a single dose. If the diuretic response is not satisfactory after the initial dose, dosage may be increased by 1 or 2 mg/kg no sooner than 6 to 8 hours after the previous dose. Doses greater than 6 mg/kg body weight are not recommended. For maintenance therapy in pediatric patients, the dose should be adjusted to the minimum effective level.

Hypertension

Therapy should be individualized according to the patient's response to gain maximal therapeutic response and to determine the minimal dose needed to maintain the therapeutic response.

Adults

The usual initial dose of Promide for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.

Changes in blood pressure must be carefully monitored when Promide is used with other antihypertensive drugs, especially during initial therapy. To prevent excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50 percent when Promide is added to the regimen. As the blood pressure falls under the potentiating effect of Promide, a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary.

Geriatric Patients

In general, dose selection and dose adjustment for the elderly patient should be cautious, usually starting at the low end of the dosing range.

How supplied

Promide (Promide) Tablets 20 mg are supplied as white, oval, monogrammed tablets in Bottles of 100 (NDC 0039-0067-10) and 1000 (NDC 0039-0067-70). The 20 mg tablets are imprinted with “Promide®” on one side.

Promide Tablets 40 mg are supplied as white, round, monogrammed, scored tablets in Bottles of 100 (NDC 0039-0060-13), 500 (NDC 0039-0060-50), and 1000 (NDC 0039-0060-70). The 40 mg tablets are imprinted with “Promide® 40” on one side.

Promide Tablets 80 mg are supplied as white, round, monogrammed, facetted edge tablets in Bottles of 50 (NDC 0039-0066-05) and 500 (NDC 0039-0066-50). The 80 mg tablets are imprinted with “Promide® 80” on one side.

Note: Dispense in well-closed, light-resistant containers. Exposure to light might cause a slight discoloration. Discolored tablets should not be dispensed.

Tested by USP Dissolution Test 2

Store at 25° C (77° F); excursions permitted to 15 -30° C (59 -86° F).

Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807. A Sanofi Company.. Revised: Mar 2016

See also:
What is the most important information I should know about Promide?

Hypersensitivity to Promide or any component of the formulation; anuria

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to sulfonamide-derived drugs; complete renal shutdown; hepatic coma and precoma; uncorrected states of electrolyte depletion, hypovolemia, dehydration, or hypotension; jaundiced newborn infants or infants with disease(s) capable of causing hyperbilirubinemia and possibly kernicterus; breast-feeding. Note: Manufacturer labeling for Promide Special and Promide Special Injection also includes: GFR <5 mL/minute or GFR >20 mL/minute; hepatic cirrhosis; renal failure accompanied by hepatic coma and precoma; renal failure due to poisoning with nephrotoxic or hepatotoxic substances.

Note: Although the approved product labeling states this medication is contraindicated with other sulfonamide-containing drug classes, the scientific basis of this statement has been challenged. See “Warnings/Precautions” for more detail.

Use Promide solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Promide solution by mouth with or without food.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you take cholestyramine, colestipol, or sucralfate, ask your doctor or pharmacist how to take them with Promide solution.
• Promide solution may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.
• If you miss a dose of Promide solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Promide solution.

Promide is used to reduce extra fluid in the body (edema) caused by conditions such as heart failure, liver disease, and kidney disease. This can lessen symptoms such as shortness of breath and swelling in your arms, legs, and abdomen.

This drug is also used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

Promide is a "water pill" (diuretic) that causes you to make more urine. This helps your body get rid of extra water and salt.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to decrease a high level of calcium in the blood (hypercalcemia).

How to use Promide

Read the Patient Information Leaflet if available from your pharmacist before you start taking Promide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, with or without food, usually once or twice daily. It is best to avoid taking this medication within 4 hours of your bedtime to prevent having to get up to urinate.

Dosage is based on your medical condition, age, and response to treatment. For children, the dose is also based on weight. Older adults usually start with a lower dose to decrease the risk of side effects. Do not increase your dose or take it more often than directed.

Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) of the day as directed. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

Sucralfate, cholestyramine, and colestipol can decrease the absorption of Promide. If you are taking any of these drugs, separate the timing of each dose from Promide by at least 2 hours.

Tell your doctor if your condition does not improve or if it worsens (for example, your blood pressure readings remain high or increase).

See also:
What other drugs will affect Promide?

Apo-Promide may increase the ototoxic potential of aminoglycoside antibiotics, especially in the presence of impaired renal function. Except in life-threatening situations, avoid this combination.

Apo-Promide should not be used concomitantly with ethacrynic acid because of the possibility of ototoxicity. Patients receiving high doses of salicylates concomitantly with Promide, as in rheumatic disease, may experience salicylate toxicity at lower doses because of competitive renal excretory sites.

Apo-Promide has a tendency to antagonize the skeletal muscle relaxing effect of tubocurarine and may potentiate the action of succinylcholine.

Lithium generally should not be given with diuretics because they reduce lithiums renal clearance and add a high risk of lithium toxicity.

Apo-Promide may add to or potentiate the therapeutic effect of other antihypertensive drugs. Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.

Apo-Promide may decrease arterial responsiveness to norepinephrine. However, norepinephrine may still be used effectively.

Tablets

Simultaneous administration of sucralfate and Promide tablets may reduce the natriuretic and antihypertensive effects of Promide. Patients receiving both drugs should be observed closely to determine if the desired diuretic and/or antihypertensive effect of Promide is achieved. The intake of Promide and sucralfate should be separated by at least two hours.

Tablets, Injection, and

Oral Solution

One study in six subjects demonstrated that the combination of Promide and acetylsalicylic acid temporarily reduced creatinine clearance in patients with chronic renal insufficiency. There are case reports of patients who developed increased BUN, serum creatinine and serum potassium levels, and weight gain when Promide was used in conjunction with NSAIDs.

Literature reports indicate that coadministration of indomethacin may reduce the natriuretic and antihypertensive effects of Promide in some patients by inhibiting prostaglandin synthesis. Indomethacin may also affect plasma renin levels, aldosterone excretion, and renin profile evaluation. Patients receiving both indomethacin and Promide should be observed closely to determine if the desired diuretic and/or antihypertensive effect of Promide is achieved.

See also:
What are the possible side effects of Promide?

Applies to Promide: oral solution, oral tablet

Other dosage forms:

• injection injectable, injection solution

In addition to its needed effects, some unwanted effects may be caused by Promide (the active ingredient contained in Promide). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Promide:

Rare

• Chest pain
• chills
• cough or hoarseness
• fever
• general feeling of tiredness or weakness
• headache
• lower back or side pain
• painful or difficult urination
• shortness of breath
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen or painful glands
• tightness in the chest
• unusual bleeding or bruising
• unusual tiredness or weakness
• wheezing

• Back or leg pains
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine or stools
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• changes in skin color, pain, tenderness, or swelling of the foot or leg
• clay-colored stools
• cloudy urine
• cold sweats
• confusion
• constipation
• continuing ringing or buzzing or other unexplained noise in the ears
• coughing up blood
• cracks in the skin
• darkened urine
• diarrhea
• difficulty breathing
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
• dry mouth
• fast heartbeat
• flushed, dry skin
• fruit-like breath odor
• greatly decreased frequency of urination or amount of urine
• hearing loss
• increased hunger
• increased thirst
• indigestion
• itching
• loss of appetite
• nausea or vomiting
• nosebleeds
• pain in the joints or muscles
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pinpoint red spots on the skin
• red, irritated eyes
• red, swollen skin
• skin rash
• spots on your skin resembling a blister or pimple
• sweating
• swelling of the feet or lower legs
• trouble breathing with exertion
• unusual weight loss
• vomiting of blood
• yellow eyes or skin

If any of the following symptoms of overdose occur while taking Promide, get emergency help immediately:

Symptoms of overdose:

• Decreased urination
• drowsiness
• increase in heart rate
• irregular heartbeat
• irritability
• mood changes
• muscle cramps
• numbness, tingling, pain, or weakness in the hands, feet, or lips
• rapid breathing
• seizures
• sunken eyes
• thirst
• trembling
• weak pulse
• weakness and heaviness of the legs
• wrinkled skin

Minor Side Effects

Some of the side effects that can occur with Promide may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Incidence not known:

• Feeling of constant movement of self or surroundings
• hives or welts
• increased sensitivity of the skin to sunlight
• muscle spasm
• redness or other discoloration of the skin
• restlessness
• sensation of spinning
• severe sunburn
• weakness

A topical anti-infective agent effective against gram-negative and gram-positive bacteria. It is used for superficial wounds, burns, ulcers, and skin infections. Promide has also been administered orally in the treatment of trypanosomiasis.