TERRAMYCIN Oxytetracycline Hydrochloride / Polymyxin B Sulfate 5mg / 10,000 units per g Ophthalmic Ointment 3.5g
RXDRUG-DRP-2067
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Oxytetracycline with Polymyxin B ophthalmic preparations are indicated in the treatment of superficial ocular infections involving the conjunctiva and/or cornea due to susceptible microorganisms.
Topical application of Oxytetracycline with Polymyxin B Ophthalmic preparation should be supplemented with systemic administration when infections are severe or do not respond to topical therapy alone.
Topical application of Oxytetracycline with Polymyxin B Ophthalmic preparation should be supplemented with systemic administration when infections are severe or do not respond to topical therapy alone.
Dosage/Direction for Use
Oxytetracycline with Polymyxin B ophthalmic preparations are administered as a small quantity (approximately 1 cm) of the ointment. The preparation should be applied into the conjunctival sac of the lower lid 4 to 6 times daily until the infection is cleared and healing is complete. This may take from one day to several weeks depending on the nature and severity of the infection. In blepharitis, scales and crusts should be removed before applying medication. For prophylaxis, the same procedure is followed on the day before the operation and subsequently for several days following it.
The patient should be instructed to avoid contamination of the tip of the tube when applying the ointment.
The patient should be instructed to avoid contamination of the tip of the tube when applying the ointment.
Overdosage
No cases of overdosage with topical use of oxytetracycline have been reported.
Contraindications
These products are contraindicated in persons who have shown hypersensitivity to Oxytetracycline HCl, Polymyxin B Sulfate and any of their components.
Special Precautions
As with other antibiotic preparations, Oxytetracycline may result in overgrowth of nonsusceptible organisms, including fungi. Constant observation of the patient for this possibility is essential. If new infections due to nonsusceptible bacteria or fungi appear during therapy, appropriate measures should be taken.
Oxytetracycline with Polymyxin B should be supplemented with systemic administration when infections are severe or do not respond to topical therapy alone.
Effects on ability to drive and use machines: Oxytetracycline topical preparations are not expected to have an influence on the ability to drive and to operate machinery. However, directly following the application of the ophthalmic dosage form, a short period of less acute vision may occur.
Use in Children: Systemic administration of tetracyclines during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth as well as retardation in the development of the skeleton. Enamel hypoplasia has also been reported. Although these effects are unlikely following topical application of tetracyclines because of the low doses used, the possibility that these effects could occur should be considered.
Oxytetracycline with Polymyxin B should be supplemented with systemic administration when infections are severe or do not respond to topical therapy alone.
Effects on ability to drive and use machines: Oxytetracycline topical preparations are not expected to have an influence on the ability to drive and to operate machinery. However, directly following the application of the ophthalmic dosage form, a short period of less acute vision may occur.
Use in Children: Systemic administration of tetracyclines during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth as well as retardation in the development of the skeleton. Enamel hypoplasia has also been reported. Although these effects are unlikely following topical application of tetracyclines because of the low doses used, the possibility that these effects could occur should be considered.
Use In Pregnancy & Lactation
Pregnancy: There are no controlled studies to date using topical tetracyclines in pregnant women. The use of systemic tetracyclines in pregnant women has resulted in retardation of skeletal development and bone growth in the fetus. Nonetheless, topical tetracyclines should be used during pregnancy only when the possible benefits outweigh the potential risks.
Lactation: It is not known whether topically applied tetracyclines are distributed into breast milk. Tetracyclines are distributed into milk following systemic administration. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Lactation: It is not known whether topically applied tetracyclines are distributed into breast milk. Tetracyclines are distributed into milk following systemic administration. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Adverse Reactions
Immune System Disorders: Hypersensitivity.
Nervous System Disorders: Burning sensation.
Eye Disorders: Lacrimation increased.
Skin & Subcutaneous Tissue Disorders: Dermatitis contact.
General Disorders and Administration Site Conditions: Pain, Sensation of foreign body.
Nervous System Disorders: Burning sensation.
Eye Disorders: Lacrimation increased.
Skin & Subcutaneous Tissue Disorders: Dermatitis contact.
General Disorders and Administration Site Conditions: Pain, Sensation of foreign body.
Caution For Usage
Incompatibilities: Not applicable.
Storage
Store at temperatures not exceeding 25°C.
Action
Therapeutic Category: Antibacterial.
Pharmacology: Pharmacodynamics: Oxytetracycline is a product of the metabolism of Streptomyces rimosus and is one of the family of tetracycline antibiotics. Oxytetracycline is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis. Oxytetracycline is active against a wide range of gram-negative and gram-positive organisms.
The drugs in the tetracycline class have similar antimicrobial spectra, and cross resistance among them is common.
Polymyxin B Sulfate, one of a group of related antibiotics derived from Bacillus polymyxa, is bactericidal. This action is exclusively against gram-negative organisms. It is thought to act by altering the structure of the bacterial membrane resulting in leakage of essential intracellular components. It is particularly effective against Pseudomonas aeruginosa and Haemophilus aegyptius, frequently found in local infections of the eye.
Thus the combination of Oxytetracycline HCl and Polymyxin B sulfate is a particularly effective antimicrobial combination against primarily causative or secondarily infecting organisms. One mg of pure Polymyxin B is equivalent to 10,000 units.
Pharmacokinetics: Oxytetracycline: In one study in rabbits with abraded corneas, oxytetracycline hydrochloride concentrations of 28 mcg/ml were detected in the aqueous humor 30 minutes after 5-minute bathing of the eye with a solution containing 5 mg/ml of oxytetracycline.
Polymyxin B: Polymyxin B is poorly absorbed from mucous membranes. In one study in rabbits, 0.1 mcg/ml concentrations of polymyxin B were detected in the aqueous humor and vitreous humor following six topical applications of 0.25% polymyxin B, one every 10 minutes.
Pharmacology: Pharmacodynamics: Oxytetracycline is a product of the metabolism of Streptomyces rimosus and is one of the family of tetracycline antibiotics. Oxytetracycline is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis. Oxytetracycline is active against a wide range of gram-negative and gram-positive organisms.
The drugs in the tetracycline class have similar antimicrobial spectra, and cross resistance among them is common.
Polymyxin B Sulfate, one of a group of related antibiotics derived from Bacillus polymyxa, is bactericidal. This action is exclusively against gram-negative organisms. It is thought to act by altering the structure of the bacterial membrane resulting in leakage of essential intracellular components. It is particularly effective against Pseudomonas aeruginosa and Haemophilus aegyptius, frequently found in local infections of the eye.
Thus the combination of Oxytetracycline HCl and Polymyxin B sulfate is a particularly effective antimicrobial combination against primarily causative or secondarily infecting organisms. One mg of pure Polymyxin B is equivalent to 10,000 units.
Pharmacokinetics: Oxytetracycline: In one study in rabbits with abraded corneas, oxytetracycline hydrochloride concentrations of 28 mcg/ml were detected in the aqueous humor 30 minutes after 5-minute bathing of the eye with a solution containing 5 mg/ml of oxytetracycline.
Polymyxin B: Polymyxin B is poorly absorbed from mucous membranes. In one study in rabbits, 0.1 mcg/ml concentrations of polymyxin B were detected in the aqueous humor and vitreous humor following six topical applications of 0.25% polymyxin B, one every 10 minutes.
MedsGo Class
Eye Anti-Infectives & Antiseptics
Features
Brand
Terramycin
GTIN
48034708
Full Details
Dosage Strength
5mg / 10.000 units per g
Drug Ingredients
- Oxytetracycline
- Polymyxin B
Drug Packaging
Ointment 3.5g
Generic Name
Oxtetracycline Hydrochloride / Polymyxin B Sulfate
Dosage Form
Ointment
Registration Number
DRP-2067
Drug Classification
Prescription Drug (RX)
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