Milk Of Magnesia Original

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Side Effects & Adverse Reactions

Embryofetal Toxicity

Some epidemiologic studies suggest that exposure to sulfamethoxazole and trimethoprim during pregnancy may be associated with an increased risk of congenital malformations, particularly neural tube defects, cardiovascular malformations, urinary tract defects, oral clefts, and club foot. If sulfamethoxazole and trimethoprim is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential hazards to the fetus.

Hypersensitivity and Other Fatal Reactions

Fatalities associated with the administration of sulfonamides, although rare, have occurred due to severe reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia and other blood dyscrasias.

Sulfonamides, including sulfonamide-containing products such as sulfamethoxazole and trimethoprim, should be discontinued at the first appearance of skin rash or any sign of adverse reaction. In rare instances, a skin rash may be followed by a more severe reaction, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, hepatic necrosis, and serious blood disorders (see PRECAUTIONS). Clinical signs, such as rash, sore throat, fever, arthralgia, pallor, purpura or jaundice may be early indications of serious reactions.

Cough, shortness of breath, and pulmonary infiltrates are hypersensitivity reactions of the respiratory tract that have been reported in association with sulfonamide treatment.

Thrombocytopenia

Sulfamethoxazole and trimethoprim-induced thrombocytopenia may be an immune-mediated disorder. Severe cases of thrombocytopenia that are fatal or life threatening have been reported. Thrombocytopenia usually resolves within a week upon discontinuation of sulfamethoxazole and trimethoprim.

Streptococcal Infections and Rheumatic Fever

The sulfonamides should not be used for treatment of group A β-hemolytic streptococcal infections. In an established infection, they will not eradicate the streptococcus and, therefore, will not prevent sequelae such as rheumatic fever.

Clostridium Difficile Associated Diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including sulfamethoxazole and trimethoprim, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Adjunctive Treatment with Leucovorin for Pneumocystis jiroveci Pneumonia

Treatment failure and excess mortality were observed when trimethoprim-sulfamethoxazole was used concomitantly with leucovorin for the treatment of HIV positive patients with Pneumocystis jiroveci pneumonia in a randomized placebo controlled trial.6 Co-administration of trimethoprim-sulfamethoxazole and leucovorin during treatment of Pneumocystis jiroveci pneumonia should be avoided.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.

Urinary Tract Infections

For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination.

Acute Otitis Media

For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim tablets offer some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim tablets, USP in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets, USP are not indicated for prophylactic or prolonged administration in otitis media at any age.

Acute Exacerbations of Chronic Bronchitis in Adults

For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim tablets, USP could offer some advantage over the use of a single antimicrobial agent.

Shigellosis

For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated.

Pneumocystis jiroveci Pneumonia

For the treatment of documented Pneumocystis jiroveci pneumonia and for prophylaxis against P.jiroveci pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jiroveci pneumonia.

Traveler's Diarrhea in Adults

For the treatment of traveler's diarrhea due to susceptible strains of enterotoxigenic E. coli.

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History

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Other Information

Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration.

Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl)sulfanilamide; the molecular formula is C10H11N3O3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula:

Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula:

Inactive Ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate.

Sources

Milk Of Magnesia Original Manufacturers

Tya Pharmaceuticals

Milk Of Magnesia Original | Avpak

Sulfamethoxazole and trimethoprim tablets are contraindicated in pediatric patients less than 2 months of age.
Urinary Tract Infections and Shigellosis in Adults and Pediatric Patients, and Acute Otitis Media in Children Adults
The usual adult dosage in the treatment of urinary tract infections is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 10 to 14 days. An identical daily dosage is used for 5 days in the treatment of shigellosis.
Children
The recommended dose for children with urinary tract infections or acute otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours, given in two divided doses every 12 hours for 10 days. An identical daily dosage is used for 5 days in the treatment of shigellosis. The following table is a guideline for the attainment of this dosage:

Children 2 months of age or older:

Weight
Dose–every 12 hours
lb
kg
Tablets
22
44
66
88
10
20
30
40
–
1
1½
2 or 1 DS tablet
For Patients with Impaired Renal Function
When renal function is impaired, a reduced dosage should be employed using the following table:

Creatinine Clearance (mL/min)
Recommended Dosage Regimen
Above 30
15–30
Below 15
Usual standard regimen
½ the usual regimen
Use not recommended
Acute Exacerbations of Chronic Bronchitis in Adults
The usual adult dosage in the treatment of acute exacerbations of chronic bronchitis is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 14 days.

Pneumocystis Jiroveci Pneumonia

Treatment

Adults and Children

The recommended dosage for treatment of patients with documented Pneumocystis jiroveci pneumonia is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours given in equally divided doses every 6 hours for 14 to 21 days.11 The following table is a guideline for the upper limit of this dosage:

Weight
Dose–every 6 hours
lb
kg
Tablets
18
35
53
70
88
106
141
176
8
16
24
32
40
48
64
80
–
1
1½
2 or 1 DS tablet
2½
3 or 1½ DS tablets
4 or 2 DS tablets
5 or 2½ DS tablets

For the lower limit dose (75 mg/kg sulfamethoxazole and 15 mg/kg trimethoprim per 24 hours) administer 75% of the dose in the above table.

Prophylaxis

Adults

The recommended dosage for prophylaxis in adults is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet daily.12

Children

For children, the recommended dose is 750 mg/m2/day sulfamethoxazole with 150 mg/m2/day trimethoprim given orally in equally divided doses twice a day, on 3 consecutive days per week. The total daily dose should not exceed 1600 mg sulfamethoxazole and 320 mg trimethoprim.13 The following table is a guideline for the attainment of this dosage in children:

Body Surface Area
Dose–every 12 hours
(m2)
Tablets
0.26
0.53
1.06
–
½
1
Traveler's Diarrhea in Adults
For the treatment of traveler’s diarrhea, the usual adult dosage is 1 sulfamethoxazole and trimethoprim DS (double strength) tablet or 2 sulfamethoxazole and trimethoprim tablets every 12 hours for 5 days.

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Best Choice

Milk Of Magnesia Original | Best Choice

shake well before use
• do not exceed the maximum recommended daily dose in a 24 hour period
• dose may be taken once a day preferably at bedtime,
in divided doses, or as directed by a doctor
• follow each dosage with a full glass (8oz) of fluid

adults and children 2-4 tablespoons (30-60 mL)
12 years and over

children 6 years to 11 years 1-2 tablespoons (15-30 mL)

children under 6 years ask a doctor

No Recall
Nash-finch Company

Milk Of Magnesia Original | Nash-finch Company

shake well before use
• do not exceed the maximum recommended daily dose in a 24 hour period
• dose may be taken once a day preferably at bedtime,
in divided doses, or as directed by a doctor
• follow each dosage with a full glass (8oz) of fluid

adults and children 2-4 tablespoons (30-60 mL)
12 years and over

children 6 years to 11 years 1-2 tablespoons (15-30 mL)

children under 6 years ask a doctor

No Recall
Premier Value

Milk Of Magnesia Original | Chain Drug Consortium, Llc

shake well before use
• do not exceed the maximum recommended daily dose in a 24 hour period
• dose may be taken once a day preferably at bedtime,
in divided doses, or as directed by a doctor
• follow each dosage with a full glass (8oz) of fluid

adults and children 2-4 tablespoons (30-60 mL)
12 years and over

children 6 years to 11 years 1-2 tablespoons (15-30 mL)

children under 6 years ask a doctor

No Recall
Walgreens

Milk Of Magnesia Original | Walgreens

shake well before use
• do not exceed the maximum recommended daily dose in a 24 hour period
• dose may be taken once a day preferably at bedtime,
in divided doses, or as directed by a doctor
• follow each dosage with a full glass (8oz) of fluid

adults and children 2-4 tablespoons (30-60 mL)
12 years and over

children 6 years to 11 years 1-2 tablespoons (15-30 mL)

children under 6 years ask a doctor

No Recall
Select Brand

Milk Of Magnesia Original | Select Brand

shake well before use
• do not exceed the maximum recommended daily dose in a 24 hour period
• dose may be taken once a day preferably at bedtime,
in divided doses, or as directed by a doctor
• follow each dosage with a full glass (8oz) of fluid

adults and children 2-4 tablespoons (30-60 mL)
12 years and over

children 6 years to 11 years 1-2 tablespoons (15-30 mL)

children under 6 years ask a doctor

No Recall
Cvs

Milk Of Magnesia Original | Cvs

shake well before use
• do not exceed the maximum recommended daily dose in a 24 hour period
• dose may be taken once a day preferably at bedtime,
in divided doses, or as directed by a doctor
• follow each dosage with a full glass (8oz) of fluid

adults and children 2-4 tablespoons (30-60 mL)
12 years and over

children 6 years to 11 years 1-2 tablespoons (15-30 mL)

children under 6 years ask a doctor

No Recall
Dollar General

Milk Of Magnesia Original | Dollar General

shake well before use
• do not exceed the maximum recommended daily dose in a 24 hour period
• dose may be taken once a day preferably at bedtime,
in divided doses, or as directed by a doctor
• follow each dosage with a full glass (8oz) of fluid

adults and children 2-4 tablespoons (30-60 mL)
12 years and over

children 6 years to 11 years 1-2 tablespoons (15-30 mL)

children under 6 years ask a doctor

No Recall
Premier Value

Milk Of Magnesia Original | Chain Drug Consortium, Llc

shake well before use
• do not exceed the maximum recommended daily dose in a 24 hour period
• dose may be taken once a day preferably at bedtime,
in divided doses, or as directed by a doctor
• follow each dosage with a full glass (8oz) of fluid

adults and children 2-4 tablespoons (30-60 mL)
12 years and over

children 6 years to 11 years 1-2 tablespoons (15-30 mL)

children under 6 years ask a doctor

No Recall
Select Brand

Milk Of Magnesia Original | Select Brand

shake well before use
• do not exceed the maximum recommended daily dose in a 24 hour period
• dose may be taken once a day preferably at bedtime,
in divided doses, or as directed by a doctor
• follow each dosage with a full glass (8oz) of fluid

adults and children 2-4 tablespoons (30-60 mL)
12 years and over

children 6 years to 11 years 1-2 tablespoons (15-30 mL)

children under 6 years ask a doctor

No Recall
Aaron Industries Inc.

Milk Of Magnesia Original | Aaron Industries Inc.

shake well before use
• do not exceed the maximum recommended daily dose in a 24 hour period
• dose may be taken once a day preferably at bedtime,
in divided doses, or as directed by a doctor
• follow each dosage with a full glass (8oz) of fluid

adults and children 2-4 tablespoons (30-60 mL)
12 years and over

children 6 years to 11 years 1-2 tablespoons (15-30 mL)

children under 6 years ask a doctor

No Recall
Geri-care Pharmaceuticals, Corp

Milk Of Magnesia Original | Geri-care Pharmaceuticals, Corp

• shake well before use
• do not exceed the maximum recommended daily dose in a 24 hour period
• dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor
• drink a full glass (8 oz) of liquid with each dose

adults and children 12 years and older: 2 to 4 tablespoonfuls
children 6 to 11 years: 1 to 2 tablespoonfuls
children under 6 years: ask a doctor

No Recall
Major Pharmaceuticals Inc.

Milk Of Magnesia Original | Major Pharmaceuticals Inc.

• shake well before use
• do not exceed the maximum recommended daily dose in a 24 hour period
• dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor
• drink a full glass (8 oz) of liquid with each dose

adults and children 12 years and older: 2 to 4 tablespoonfuls (TBSP)
children 6 to 11 years: 1 to 2 tablespoonfuls (TBSP)
children under 6 years: ask a doctor

No Recall
Preferred Pharmaceuticals, Inc.

Milk Of Magnesia Original | Preferred Pharmaceuticals, Inc.

• shake well before use
• do not exceed the maximum recommended daily dose in a 24 hour period
• dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor
• drink a full glass (8 oz) of liquid with each dose

adults and children 12 years and older: 2 to 4 tablespoonfuls
children 6 to 11 years: 1 to 2 tablespoonfuls
children under 6 years: ask a doctor

No Recall
Atlantic Biologicals Corps

Milk Of Magnesia Original | Atlantic Biologicals Corps

• shake well before use • do not exceed the maximum recommended daily dose in a 24 hour period • dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor • drink a full glass (8 oz) of liquid with each dose adults and children 12 years and older: 2 to 4 tablespoonfuls (TBSP) children 6 to 11 years: 1 to 2 tablespoonfuls (TBSP) children under 6 years: ask a doctor

No Recall
Chain Drug Marketing Association

Milk Of Magnesia Original | Chain Drug Marketing Association

• shake well before use

• do not exceed the maximum recommended daily dose in a 24 hour period

• dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor

• follow each dosage with a full glass (8 oz) of liquid

adults and children 12 years and over: 2 to 4 tablespoonfuls (TBSP)

children 6 to 11 years: 1 to 2 tablespoonfuls (TBSP)

children under 6 years: ask a doctor

No Recall
Mckesson

Milk Of Magnesia Original | Mckesson

shake well before use do not exceed the maximum recommended daily dose in a 24 hour period dose may be taken once a day preferably at bedtime, in divided doses, or as directed by a doctor follow each dosage with a full glass (8 oz) of fluid use dosage cup provided tbsp = tablespoon adults and children 12 years and over 2 - 4 tablespoons children 6 to 11 years 1- 2 tablespoons children under 6 years ask a doctor

No Recall