Antibacterial

Oral Suspension
106 mg/106 mg/106 mg per 5 mL

SULTRINE
Sulfamethazine
Sulfamerazine
Sulfadiazine

60 mL Formulation: 60 mL Contraindications:
Sulfadiazine Each 5 mL contains: Sulfadiazine Porphyria, known
Sulfadiazine ................... 106 mg hypersensitivity to any sulfa
Sulfamerazine Sulfamerazine ................ 106 mg
Sulfamerazine drug or component
Sulfamethazine Sulfamethazine .............. 106 mg
Sulfamethazine
Precaution:
SULTRINE ® Indication: SULTRINE ® This medication may cause
106 mg/106 mg/106 mg per 5 mL For the treatment of rheumatic 106 mg/106 mg/106 mg per 5 mL stomach upset, diarrhea, nausea,
Oral Suspension fever and meningococcal Oral Suspension headache, or vomiting during the
meningitis. first few days as your body
adjusts to the medication.
Antibacterial Antibacterial
Dose:
As directed by the physician. Storage:
Keep tightly closed in a cool, dry
Caution: place. Keep out of reach of
Food, Drugs, Cosmetics and children.
Devices Law prohibits
dispensing without a
prescription. SHAKE WELL
BEFORE USING.
Manufactured and Distributed by: Manufactured and Distributed by:

DC Northbound DC Northbound
Lab, Inc. Mfg Date 28 Nov 2017 Lab, Inc. REGISTRATION NO.:
DRP-0004-3AG3
Km 44, McArthur Highway, Exp Date Nov 2020 Km 44, McArthur Highway, BATCH NO.:
City of Malolos, Bulacan, City of Malolos, Bulacan, BSPAG3-04-2017
Philippines Philippines

Mfg Date 28 Nov 2017

Exp Date Nov 2020

Formulation:
Each 5 mL contains:
60 mL
Sulfadiazine ............................................................................ 106 mg Sulfadiazine
Sulfamerazine ......................................................................... 106 mg
Sulfamethazine ....................................................................... 106 mg
Sulfamerazine
Sulfamethazine
Indication:
For the treatment of rheumatic fever and meningococcal meningitis.
SULTRINE ®
Dose:
106 mg/106 mg/106 mg per 5 mL
As directed by the physician.
Oral Suspension
Storage: Antibacterial
Keep tightly closed in a cool, dry place. Keep out of reach of children.

Contraindications:
Porphyria, known hypersensitivity to any sulfa drug or component

SHAKE WELL BEFORE USE.

Manufactured and Distributed by:

Registration No. : DRP-0004-3AG3 Mfg Date: 28 Nov 2017 DC Northbound Lab, Inc.
Km 44, McArthur Highway,
Batch No.: BSPAG3-04-2017 Exp Date : Nov 2020 City of Malolos, Bulacan,
Philippines
 Sulfadiazine
Sulfamerazine
Sulfamethazine

SULTRINE ®
106 mg/106 mg/106 mg per 5 mL
Oral Suspension
Antibacterial

FORMULATION
Each 5 mL contains:
Sulfadiazine ..................................................................................................................................................................................................................................................... 160 mg
Sulfamerazine ................................................................................................................................................................................................................................................. 160 mg
Sulfamethazine ............................................................................................................................................................................................................................................... 160 mg

PHARMACOLOGY
Sulfadiazine
Sulfadiazine is a sulfonamide antibiotic. The sulfonamides are synthetic bacteriostatic antibiotics with a wide spectrum against most gram-positive and many gram-
negative organisms. However, many strains of an individual species may be resistant. Sulfonamides inhibit multiplication of bacteria by acting as competitive inhibitors
of p-aminobenzoic acid in the folic acid metabolism cycle. Bacterial sensitivity is the same for the various sulfonamides, and resistance to one sulfonamide indicates
resistance to all. Most sulfonamides are readily absorbed orally. However, parenteral administration is difficult, since the soluble sulfonamide salts are highly alkaline
and irritating to the tissues. The sulfonamides are widely distributed throughout all tissues. High levels are achieved in pleural, peritoneal, synovial, and ocular fluids.
Although these drugs are no longer used to treat meningitis, CSF levels are high in meningeal infections. Their antibacterial action is inhibited by pus.
Sulfadiazine is a competitive inhibitor of the bacterial enzyme dihydropteroate synthetase. This enzyme is needed for the proper processing of para-aminobenzoic acid
(PABA) which is essential for folic acid synthesis. The inhibited reaction is necessary in these organisms for the synthesis of folic acid.
Sulfamerazine
Sulfonamides act as competitive inhibitors of the enzyme dihydropteroate synthetase (DHPS), an enzyme involved in folate synthesis in bacteria.
Sulfamerazine is a sulfonamide drug that inhibits bacterial synthesis of dihydrofolic acid by competing with para-aminobenzoic acid (PABA) for binding to
dihydropteroate synthetase (dihydrofolate synthetase). Sulfamerazine is bacteriostatic in nature. Inhibition of dihydrofolic acid synthesis decreases the synthesis of
bacterial nucleotides and DNA.
Sulfamethazine
Sulfamethazine is a sulfonamide drug that inhibits bacterial synthesis of dihydrofolic acid by competing with para-aminobenzoic acid (PABA) for binding to
dihydropteroate synthetase (dihydrofolate synthetase). Sulfamethazine is bacteriostatic in nature. Inhibition of dihydrofolic acid synthesis decreases the synthesis of
bacterial nucleotides and DNA.
Sulfonamides inhibit the enzymatic conversion of pteridine and p-aminobenzoic acid (PABA) to dihydropteroic acid by competing with PABA for binding to dihydrofolate
synthetase, an intermediate of tetrahydrofolic acid (THF) synthesis. THF is required for the synthesis of purines and dTMP and inhibition of its synthesis inhibits bacterial
growth. Pyrimethamine and trimethoprim inhibit dihydrofolate reductase, another step in THF synthesis, and therefore act synergistically with the sulfonamides.

RATIONALE OF COMBINATION
The combination of three structurally different sulfonamides allows a high total sulfonamide dose to be administered with a relatively low risk of crystalluria.

INDICATIONS
• For the treatment of rheumatic fever and meningococcal meningitis

DOSAGE AND ADMINISTRATION

As directed by the physician

CONTRAINDICATIONS
Sultrine® is contraindicated in the following circumstances: Hypersensitivity to sulfonamides.
In infants less than 2 months of age (except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis).
In pregnancy at term and during the nursing period, because sulfonamides cross the placenta and are excreted in breast milk and may cause kernicterus.

WARNINGS
The sulfonamides should not be used for the treatment of group A betahemolytic streptococcal infections. In an established infection, they will not eradicate the
streptococcus and, therefore, will not prevent sequelae such as rheumatic fever and glomerulonephritis.
Deaths associated with the administration of sulfonamides have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia and other blood
dyscrasias.
The presence of such clinical signs as sore throat, fever, pallor, purpura or jaundice may be early indications of serious blood disorders.
The frequency of renal complications is considerably lower in patients receiving the more soluble sulfonamides.

PRECAUTIONS
Sulfonamides should be given with caution to patients with impaired renal or hepatic function and to those with severe allergy or bronchial asthma.
Hemolysis may occur in individuals deficient in glucose-6-phosphate dehydrogenase. This reaction is dose related.
Adequate fluid intake must be maintained in order to prevent crystalluria and stone formation.
Patients should be instructed to drink an eight ounce glass of water with each dose of medication and at frequent intervals throughout the day. Caution patients to report
promptly the onset of sore throat, fever, pallor, purpura or jaundice when taking this drug, since these may be early indications of serious blood disorders.
Complete blood counts and urinalyses with careful microscopic examinations should be done frequently in patients receiving sulfonamides.

ADVERSE DRUG REACTIONS

Blood Dyscrasias
Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, hemolytic anemia, purpura, hypoprothrombinemia and methemoglobinemia.
Allergic Reactions
Erythema multiforme, generalized skin eruptions, epidermal necrolysis, urticaria, serum sickness, pruritus, exfoliative dermatitis, anaphylactoid reactions, periorbital
edema, conjunctival and scleral injection, photosensitization, arthralgia, allergic myocarditis, drug fever and chills. Gastrointestinal Reactions Nausea, emesis,
abdominal pains, hepatitis, diarrhea, anorexia, pancreatitis and stomatitis.
C.N.S. Reactions
Headache, peripheral neuritis, mental depression, convulsions, ataxia, hallucinations, tinnitus, vertigo and insomnia.
Renal Crystalluria, stone formation, toxic nephrosis with oliguria and anuria; periarteritis nodosa and lupus erythematosus phenomenon have been noted.
Miscellaneous Reactions
The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Goiter production,
diuresis, and hypoglycemia have occurred rarely in patients receiving sulfonamides. Cross-sensitivity may exist with these agents.

DRUG INTERACTIONS
Administration of a sulfonamide may increase the effect of oral anticoagulants and methotrexate, probably by displacement of these drugs from binding sites on plasma
albumin. Potentiation of the action of sulfonylurea hypoglycemic agents, thiazide diuretics and uricosuric agents may also be noted. This may also be due to
displacement of the drugs from albumin or a pharmacodynamic mechanism may play a role. Conversely, agents such as indomethacin, probenecid and salicylates may
displace sulfonamides from plasma albumin and increase the concentrations of free drug in plasma.

AVAILABILITY
Suspension in 60 mL bottle.

CAUTION
Food, Drugs, Cosmetics and Devices Law prohibits dispensing without a prescription.

STORE IN A COOL, DRY PLACE. PROTECT FROM LIGHT. DO NOT FREEZE. DO NOT USE IF THE SOLUTION IS DICOLORED.

Manufactured and Distributed by

DC Northbound Lab, Inc.
Km 44, McArthur Highway, City of Malolos, Bulacan, Philippines

Registered
Dare of Revision : 11/2017
 Sulfadiazine
Sulfamerazine
Sulfamethazine

SULTRINE ®
106 mg/106 mg/106 mg per 5 mL
Oral Suspension
Antibacterial

FORMULATION
Each 5 mL contains:
Sulfadiazine ..................................................................................................................................................................................................................................................... 160 mg
Sulfamerazine ................................................................................................................................................................................................................................................. 160 mg
Sulfamethazine ............................................................................................................................................................................................................................................... 160 mg

PHARMACOLOGY
Sulfadiazine
Sulfadiazine is a sulfonamide antibiotic. The sulfonamides are synthetic bacteriostatic antibiotics with a wide spectrum against most gram-positive and many gram-
negative organisms. However, many strains of an individual species may be resistant. Sulfonamides inhibit multiplication of bacteria by acting as competitive inhibitors
of p-aminobenzoic acid in the folic acid metabolism cycle. Bacterial sensitivity is the same for the various sulfonamides, and resistance to one sulfonamide indicates
resistance to all. Most sulfonamides are readily absorbed orally. However, parenteral administration is difficult, since the soluble sulfonamide salts are highly alkaline
and irritating to the tissues. The sulfonamides are widely distributed throughout all tissues. High levels are achieved in pleural, peritoneal, synovial, and ocular fluids.
Although these drugs are no longer used to treat meningitis, CSF levels are high in meningeal infections. Their antibacterial action is inhibited by pus.
Sulfadiazine is a competitive inhibitor of the bacterial enzyme dihydropteroate synthetase. This enzyme is needed for the proper processing of para-aminobenzoic acid
(PABA) which is essential for folic acid synthesis. The inhibited reaction is necessary in these organisms for the synthesis of folic acid.
Sulfamerazine
Sulfonamides act as competitive inhibitors of the enzyme dihydropteroate synthetase (DHPS), an enzyme involved in folate synthesis in bacteria.
Sulfamerazine is a sulfonamide drug that inhibits bacterial synthesis of dihydrofolic acid by competing with para-aminobenzoic acid (PABA) for binding to
dihydropteroate synthetase (dihydrofolate synthetase). Sulfamerazine is bacteriostatic in nature. Inhibition of dihydrofolic acid synthesis decreases the synthesis of
bacterial nucleotides and DNA.
Sulfamethazine
Sulfamethazine is a sulfonamide drug that inhibits bacterial synthesis of dihydrofolic acid by competing with para-aminobenzoic acid (PABA) for binding to
dihydropteroate synthetase (dihydrofolate synthetase). Sulfamethazine is bacteriostatic in nature. Inhibition of dihydrofolic acid synthesis decreases the synthesis of
bacterial nucleotides and DNA.
Sulfonamides inhibit the enzymatic conversion of pteridine and p-aminobenzoic acid (PABA) to dihydropteroic acid by competing with PABA for binding to dihydrofolate
synthetase, an intermediate of tetrahydrofolic acid (THF) synthesis. THF is required for the synthesis of purines and dTMP and inhibition of its synthesis inhibits bacterial
growth. Pyrimethamine and trimethoprim inhibit dihydrofolate reductase, another step in THF synthesis, and therefore act synergistically with the sulfonamides.

RATIONALE OF COMBINATION
The combination of three structurally different sulfonamides allows a high total sulfonamide dose to be administered with a relatively low risk of crystalluria.

INDICATIONS
• For the treatment of rheumatic fever and meningococcal meningitis

DOSAGE AND ADMINISTRATION

As directed by the physician

CONTRAINDICATIONS
Sultrine® is contraindicated in the following circumstances: Hypersensitivity to sulfonamides.
In infants less than 2 months of age (except as adjunctive therapy with pyrimethamine in the treatment of congenital toxoplasmosis).
In pregnancy at term and during the nursing period, because sulfonamides cross the placenta and are excreted in breast milk and may cause kernicterus.

WARNINGS
The sulfonamides should not be used for the treatment of group A betahemolytic streptococcal infections. In an established infection, they will not eradicate the
streptococcus and, therefore, will not prevent sequelae such as rheumatic fever and glomerulonephritis.
Deaths associated with the administration of sulfonamides have been reported from hypersensitivity reactions, agranulocytosis, aplastic anemia and other blood
dyscrasias.
The presence of such clinical signs as sore throat, fever, pallor, purpura or jaundice may be early indications of serious blood disorders.
The frequency of renal complications is considerably lower in patients receiving the more soluble sulfonamides.

PRECAUTIONS
Sulfonamides should be given with caution to patients with impaired renal or hepatic function and to those with severe allergy or bronchial asthma.
Hemolysis may occur in individuals deficient in glucose-6-phosphate dehydrogenase. This reaction is dose related.
Adequate fluid intake must be maintained in order to prevent crystalluria and stone formation.
Patients should be instructed to drink an eight ounce glass of water with each dose of medication and at frequent intervals throughout the day. Caution patients to report
promptly the onset of sore throat, fever, pallor, purpura or jaundice when taking this drug, since these may be early indications of serious blood disorders.
Complete blood counts and urinalyses with careful microscopic examinations should be done frequently in patients receiving sulfonamides.

ADVERSE DRUG REACTIONS

Blood Dyscrasias
Agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, hemolytic anemia, purpura, hypoprothrombinemia and methemoglobinemia.
Allergic Reactions
Erythema multiforme, generalized skin eruptions, epidermal necrolysis, urticaria, serum sickness, pruritus, exfoliative dermatitis, anaphylactoid reactions, periorbital
edema, conjunctival and scleral injection, photosensitization, arthralgia, allergic myocarditis, drug fever and chills. Gastrointestinal Reactions Nausea, emesis,
abdominal pains, hepatitis, diarrhea, anorexia, pancreatitis and stomatitis.
C.N.S. Reactions
Headache, peripheral neuritis, mental depression, convulsions, ataxia, hallucinations, tinnitus, vertigo and insomnia.
Renal Crystalluria, stone formation, toxic nephrosis with oliguria and anuria; periarteritis nodosa and lupus erythematosus phenomenon have been noted.
Miscellaneous Reactions
The sulfonamides bear certain chemical similarities to some goitrogens, diuretics (acetazolamide and the thiazides) and oral hypoglycemic agents. Goiter production,
diuresis, and hypoglycemia have occurred rarely in patients receiving sulfonamides. Cross-sensitivity may exist with these agents.

DRUG INTERACTIONS
Administration of a sulfonamide may increase the effect of oral anticoagulants and methotrexate, probably by displacement of these drugs from binding sites on plasma
albumin. Potentiation of the action of sulfonylurea hypoglycemic agents, thiazide diuretics and uricosuric agents may also be noted. This may also be due to
displacement of the drugs from albumin or a pharmacodynamic mechanism may play a role. Conversely, agents such as indomethacin, probenecid and salicylates may
displace sulfonamides from plasma albumin and increase the concentrations of free drug in plasma.

AVAILABILITY
Suspension in 60 mL bottle.

CAUTION
Food, Drugs, Cosmetics and Devices Law prohibits dispensing without a prescription.

STORE IN A COOL, DRY PLACE. PROTECT FROM LIGHT. DO NOT FREEZE. DO NOT USE IF THE SOLUTION IS DICOLORED.

Manufactured and Distributed by

DC Northbound Lab, Inc.
Km 44, McArthur Highway, City of Malolos, Bulacan, Philippines

Registered
Date of Revision : 11/2017