Antibiotic Case No 11.Tetracycline Group Medicine

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Antibiotic Case No 11.Tetracycline Group Medicine

1.Doxycycline Hydrochloride.

2.Lymecycline.

3.Minocycline Hydrochloride.

4.Oxytetracycline.

5.Tetracycline Hydrochloride(Oral).

6.Tigecycline.

1.Doxycycline Hydrochloride:-

Capsule 1.Doxacil 100 mg (AS A Doxycycline Hydrochloride AS A Tetracycline group of drugs).

Capsule 2.Doxicap 50 mg. (AS A Doxycycline Hydrochloride AS A Tetracycline group of drugs).

Indications of Doxycycline Hydrochloride:-

Doxacil is indicated in the following infections caused by susceptible microorganisms:

Respiratory tract infections: Pneumonia, influenza, sinusitis, bronchitis, tonsillitis, tracheitis.
Gastrointestinal tract infections: Cholera, traveler’s diarrhea, shigella dysentery, acute intestinal amebiasis.
Chlamydial infections: Lympho-granuloma venereum, psittacosis, trachoma.
Sexually transmitted diseases: Non gonococcal urethritis, acute pelvic inflammatory disease, uncomplicated urethral and endocervical or rectal infections, gonorrhoea, syphilis, pyelonephritis, cystitis.
Other infections: Impetigo, furunculosis, inclusion conjunctivitis, brucellosis, tularemia, cellulitis, acne and Q-fever.

Description

Doxacil is a highly active broad-spectrum antibiotic of tetracycline group. It is effective against a wide range of Gram-positive and Gram-negative bacteria, spirochete, mycoplasma, rickettsia and mycobacteria. Doxacil is used as an alternate to penicillin in the treatment of gonorrhoea and syphilis. Doxacil has its main mechanism of action on protein synthesis. Inside the bacterial cell, it inhibits protein synthesis.

Pharmacology

Doxycycline Hydrochloride is a semisynthetic tetracycline antibiotic with broad spectrum activity. It is primarily a bacteriostatic antibiotic. It has a similar spectrum of activity to other tetracyclines but in particular is more active against Staphylococcus aureus and Nocardia. The drug is often active against penicillin-resistant strains of Staphylococcus aureus and against strains of those organisms that are resistant to other Tetracyclines. Certain Gram-negative strains of E. coli, Proteus mirabilis and Klebsiella, which are often resistant to Tetracycline, may be sensitive to Doxycycline. In addition, 70-90% of the various anaerobes are sensitive to Doxycycline and Bacteroides fragilis is more likely to be sensitive to Doxycycline than to other tetracyclines.

Doxycycline is active against most strains of Haemophilus influenzaeand is particularly useful for infections with H. ducreyi, Actinomyces, Brucella and Vibrio cholerae. It is also active against Nocardia, Chlamydia, Mycoplasma and a wide range of Rickettsiae. Doxycycline is active against spirochetes such as Borellia recurrentis, Treponema pallidum and Treponema pertenue. It is also active against Plasmodium falciparum.

Dosage

Usual dose: 200 mg on first day, then 100 mg daily for 7-10 days.
Severe infections (including refractory urinary tract infections): 200 mg daily for 10 days.
Acne: 100 mg daily.
Uncomplicated genital chlamydia, non-gonococcal urethritis: 100 mg twice daily for 7-21 days (14-21 days in pelvic inflammatory disease).

Administration

Capsules should be swallowed whole with plenty of fluid during meals while sitting or standing.

Interaction

Absorption of tetracyclines is impaired by antacid containing aluminium, calcium or magnesium, and iron containing preparation. Absorption of tetracyclines is also impaired by bismuth salicylate. Barbiturates, carbamazepine and phenytoin decrease half-life of doxycycline. Concurrent use of tetracyclines may render oral contraceptive less effective. Patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosages. It is advisable to avoid giving tetracyclines in conjunction with penicillin.

Contraindications

Doxycycline is contraindicated to the patients who have shown hypersensitivity to any of the tetracyclines. Doxycycline is contraindicated to the children under 8 years of age. It is also contraindicated to pregnant women and to the lactating mothers.

Side Effects

Nausea, vomiting, diarrhoea, skin rashes, hemolytic anaemia, eosinophilia may be reported.

Pregnancy & Lactation

Doxycycline should be avoided in pregnant women, because of the risk of both staining and effect on bone growth in the foetus. Doxycyclines enter breast milk, and mothers taking these drugs should not breastfeed their child.

Precautions & Warnings

The use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy and childhood to the age of 8 years) may cause permanent discoloration of teeth. Tetracyclines drugs, therefore should not be used in this age group.

Therapeutic Class of Doxycycline Hydrochloride:-

Tetracycline group of drugs

2.Lymecycline:-

Capsule 1.Lymeclin 408 mg (AS A Lymecycline AS A Tetracycline group of drugs).

Indications of Lymecycline:-

Lymeclin is indicated for the treatment of acne, ear, nose and throat infections, acute exacerbation of chronic bronchitis, gastro-intestinal infection, urinary tract infection, non-gonococcal urethritis, trachoma, rickettsial fever, soft tissue infection.

Pharmacology

Lymecycline is is approximately 5000 times more soluble than tetracycline base and is unique amongst tetracyclines in that it is absorbed by an active transport process across the intestinal wall, ensuring greater absorption.

Lymecycline is a tetracycline derivative which blocks the access of bacterial aminoacyl-tRNA to the mRNA-ribosome complex by binding to the 30S ribosome subunit, preventing the addition of amino acids to the growing peptide chain in protein synthesis

Dosage & Administration

Adults: The usual dosage for the chronic treatment of acne is 1 capsule daily: Treatment should be continued for at least 8 weeks. For other infections, the usual dosage is 1 capsule twice daily. If higher doses are required, 3-4 capsules may be given over 24 hours. Duration should be determined by the physician. Lower doses may be given for prophylaxis.

Elderly: As for other tetracyclines, no specific dose adjustment is required.

Children: Not recommended for children under the age of 12 years. For children over the age of 12 years the adult dosage may be given.

Lymecycline capsule should always be taken with a glass of water.

Interaction

The absorption of tetracyclines may be affected by the simultaneous administration of Calcium, Aluminium, Magnesium, Bismuth and Zinc salts, antacids, iron preparations and quinapril. These products should not be taken within two hours before or after taking Lymeclin. Unlike earlier tetracyclines, absorption of Lymeclin is not significantly impaired by moderate amounts of milk. An increase in the effects of anticoagulants may occur with tetracyclines. Concomitant use of diuretics should be avoided.

Contraindications

Hypersensitivity to lymecycline or other tetracyclines. Overt renal insufficiency. Pregnancy and lactation. Concomitant use with methoxuflurane or oral retinoids.

Side Effects

Care should be exercised in administering Lymeclin to patients with hepatic impairment.

Pregnancy & Lactation

Lymecycline are selectively absorbed by developing bones and teeth and may cause dental staining and enamel hypoplasia. In addition, these compounds readily cross the placental barrier and therefore Lymecycline should not be given to pregnant or lactating women.

Precautions & Warnings

Patient with myasthenia gravis. May exacerbate SLE. Hepatic impairment.

Overdose Effects

There is no specific treatment, but gastric lavage should be performed as soon as possible. Supportive measure should be instituted as required and a high fluid intake maintained.

Therapeutic Class of Lymecycline:-

Tetracycline group of drugs

3.Minocycline Hydrochloride:-

Tablet 1.Minocin 100mg (AS A Minocycline Hydrochloride AS A Tetracycline group of drugs).

Capsule 2.Minocin 50 mg (AS A Minocycline Hydrochloride AS A Tetracycline group of drugs).

Indications of Minocycline Hydrochloride:-

Minocin is indicated for oral administration, for the treatment of infections caused by tetracycline sensitive organisms and some tetracycline resistant strains of staphylococci.

Indications include: Acne, skin and soft tissue infections, ophthamological infections, acute and chronic bronchitis, bronchiectasis, lung abscess, ear, nose and throat infections, pelvic inflammatory disease, nocardiosis, urinary tract infections, gonorrhoea, non-gonococcal urethritis and prostatitis. Minocin may also be used in prophylactic treatment of asymptomatic meningococcal carriers. Also indicated in pre- and post-operative prophylaxis of infection.

Dosage & Administration

Routine antibiotic use: 200 mg daily in divided doses
Acne: 50 mg twice daily for at least 6 weeks.
Gonorrhoea: Males: 200 mg initially followed by 100 mg every 12 hours for a minimum of 4 days. Post therapy cultures within 2-3 days. Females: May require a more prolonged therapy.
Prophylaxis of asymptomatic meningococcal carriers: 100 mg twice daily for 5 days, followed by treatment with rifampicin.

If, after six months, there is no satisfactory response minocycline should be discontinued and other therapies considered. If minocycline is to be continued for longer than six months, patients should be monitored at least three monthly intervals thereafter for signs and symptoms of hepatitis or SLE.

Interaction

Anticoagulants: Plasma prothrombin activity is depressed by tetracyclines. Reduced doses of any concomitant anticoagulants may be necessary.
ACE inhibitors, antacids and adsorbants: Tetracyclines bind to di-/tri-valent cations. Absorption from the gastrointestinal tract is impaired by the concomitant administration of iron, calcium, aluminium, magnesium, bismuth and zinc salt (interactions with specified salts, antacids, kaolin, bismuth containing ulcer-healing drugs, quinapril which contains a magnesium carbonate excipient). Dosages should be maximally separated. Absorption of tetracyclines is not significantly impaired by food, milk and milk products.
Diuretics: Diuretics may aggravate nephrotoxicity by volume depletion.
Antibacterials: Minocin should not be used with penicillins.
Ergotamine and ergometrine: There is an increased risk of ergotism.
Oral contraceptives: Both can induce hyperpigmentation.
Retinoids: Administration of isotretinoin should be avoided shortly before, during and shortly after minocycline therapy.

Contraindications

Minocycline is contraindicated in patients with hypersensitivity to tetracyclines, systemic lupus erythematosus, pregnancy, lactation, complete renal failure and children under 12 years.

Side Effects

Reported side effects are oral and anogenital candidiasis, vulvovaginitis, eosinophilia, leucopenia, neutropenia, thrombocytopenia, haemolytic anaemia, pancytopenia, agranulocytosis, anaphylaxis, anaphylactoid reaction, hypersensitivity, pulmonary infiltrates, anaphylactoid purpura, polyarthritisnodosa, abnormal thyroid function, brown-black discolouration of the thyroid, anorexia, dizziness, headache, hypaesthesia, paraesthesia, intracranial hypertension, vertigo, Bulging fontanelle, convulsions, sedation, impaired hearing, tinnitus, myocarditis, pericarditis, cough, dyspnoea, bronchospasm, exacerbation of asthma, pulmonary eosinophilia, pneumonitis, diarrhoea, nausea, stomatitis, discolouration of teeth, vomiting, dyspepsia, dysphagia, enamel hypoplasia, enterocolitis, oesophagitis, oesophageal ulceration, glossitis, pancreatitis, pseudomembranous colitis, increased liver enzymes, hepatitis, autoimmune hepatotoxicity, hepatic cholestatis, hepatic failure, hyperbilirubinemia, jaundice, autoimmune hepatitis, alopecia, erythema multiforme, erythema nodosum, fixed drug eruption, hyperpigmentation of the skin, photosensitivity, pruritis, rash, urticaria, vasculitis, angioedema, exfoliative dermatitis, hyperpigmentation of nails, Stevens-Johnson syndrome, toxic epidermal necrolysis, Drug reaction with eosinophilia and systemic symptoms (DRESS), arthralgia, lupus-like syndrome, myalgia, arthritis, bone discolouration, cases of systemic lupus erythematous (SLE), joint stiffness, joint swelling, increased serum urea, acute renal failure, interstitial nephritis, balanitis, fever, etc. In some cases involving these syndromes, death has been reported.

Hyperpigmentation of various body sites including the skin, nails, teeth, oral mucosa, bones, thyroid, eyes (including sclera and conjunctiva), breast milk, lacrimal secretions and perspiration has been reported. This blue/black/grey or muddy-brown discolouration may be localised or diffuse. The most frequently reported site is in the skin. Pigmentation is often reversible on discontinuation of the drug, although it may take several months or may persist in some cases. The generalised muddy-brown skin pigmentation may persist, particularly in areas exposed to the sun.

Pregnancy & Lactation

Minocycline use during pregnancy and lactation is contraindicated. Animal studies have indicated that tetracyclines cross the placenta. Tetracyclines have been found in foetal tissues and can have toxic effects on the developing foetus (related to retardation of skeletal development). Studies on animals treated during early pregnancy also indicate embryotoxicity. The use of tetracyclines during the last half of pregnancy, when the teeth are developing, may cause permanent discolouration of teeth (more common with long term or repeated short term use). Enamel hypoplasia has also been reported. Tetracyclines have been detected in the milk of lactating women. Permanent tooth discolouration may occur in the developing infant and enamel hypoplasia has been reported.

Precautions & Warnings

Breathing difficulties: Cases of breathing difficulties including dyspnoea, bronchospasm, exacerbation of asthma, pulmonary eosinophilia and pneumonitis have been reported with minocycline use. If patients develop breathing difficulties they should seek urgent medical advice and minocycline should be discontinued.

Paediatric population: All tetracyclines form a stable calcium complex in any bone forming tissue. An increase in the fibula growth rate has been observed in premature babies administered oral tetracyclines. Tetracyclines are known to cause a yellow to brown discoloration of the teeth and enamel hypoplasia in the developing child or foetus.

Hepatic impairment: Minocin should be used with caution in patients with hepatic dysfunction or in conjunction with potentially hepatotoxic drugs, including alcohol.

Auto-immune disorders: Rare cases of auto-immune hepatotoxicity and isolated cases of systemic lupus erythematosus (SLE) have been reported. If patients develop signs or symptoms of SLE or hepatotoxicity, minocycline should be discontinued.

Renal impairment: Studies indicate there is no significant drug accumulation in patients with mild to moderate renal impairment when treated with the recommended dosages of minocycline. In cases of severe renal impairment a reduction of dosage and monitoring of renal function may be required.

Cross-sensitivities: Micro-organisms can develop cross resistance to tetracyclines and patients can develop cross sensitivity. Minocin should be discontinued there are signs/symptoms of overgrowth of resistant organisms.

Intracranial hypertension: As with other tetracyclines, bulging fontanelles in infants and benign intracranial hypertension in juveniles and adults have been reported. Presenting features were headache and visual disturbances including blurring of vision, scotoma and diplopia. Permanent vision loss has been reported. Treatment should cease if evidence of raised intracranial pressure develops.

Hyperpigmentation: As with other tetracyclines, minocycline may cause hyperpigmentation at various body sites. Hyperpigmentation may present regardless of dose or duration of therapy but develops more commonly during long term treatment. Patients should be advised to report any unusual pigmentation without delay and minocycline should be discontinued.

Photosensitivity: Tetracyclines are known to cause photosensitivity reactions. Such patients should be warned to avoid direct exposure to natural or artificial sunlight and to discontinue therapy at the first sign of skin discomfort.

Use in Special Populations

Renal impairment: As adults even in cases of mild to moderate renal impairment. However, caution is advised in patients with severe renal impairment.
Paediatric population: Minocin is not recommended in children under 12 years. Children over 12 years: 50mg every 12 hours.

Overdose Effects

Dizziness, nausea and vomiting are the adverse effects most commonly seen in overdose. Gastric lavage plus appropriate supportive treatment. Antacids and calcium salts will reduce absorption of minocycline but there is no specific antidote. Minocin is not removed in significant quantities by haemodialysis or peritoneal dialysis.

Therapeutic Class of Minocycline Hydrochloride:-

Tetracycline group of drugs

4.Oxytetracycline:-

Capsule 1.Renamycin 250 mg (AS A Oxytetracycline AS A Eye Anti-Infectives & Antiseptics, Tetracycline group of drugs, Topical antibiotics for Acne).

Capsule 2.Renamycin 500 mg (AS A Oxytetracycline AS A Eye Anti-Infectives & Antiseptics, Tetracycline group of drugs, Topical antibiotics for Acne).

Indications of Oxytetracycline:-

Renamycin is indicated in-

Respiratory tract infections
Mycoplasma pneumonia
Urinary tract infections
Sexually transmitted diseases: Infections due to Chlamydia trachomatis including uncom-plicated urethral, endocervical or rectal infections, non gonococcal urethritis, chancroid, granuloma inguinale, lymphogranuloma venereum, gonorrhoea, syphilis
Skin infections: Acne and rosacea
Ophthalmic infections: Trachoma
Rickettsial infections
Other infections: Psittacosis, brucellosis, cholera, acute intestinal amoebiasis etc.

Description

Renamycin is primarily a bacteriostatic broad-spectrum antibiotic, which has a wide spectrum of activity against Gram-positive and Gram-negative microorganisms. Usually Renamycin acts as an antimicrobial agent by inhibiting the protein synthesis of bacteria. It is also very effective against parasites such as rickettsia, mycoplasma, chlamydia and amoeba etc.

Pharmacology

Dosage & Administration

Adults: 250-500 mg every 6 hours. Food, milk and some dairy products interfere with the absorption of Tetracyclines. So Tetracyclines should be given one hour before or two hours after meals.

Interaction

Antacids containing Aluminium, Calcium, Magnesium, Zinc or Iron salts may impair the absorption of Renamycin. In long term therapy, Tetracyclines depress plasma prothrombin activity and reduced doses of concomitant anticoagulants may be necessary. A few cases of pregnancy or breakthrough bleeding have been attributed to the concurrent use of Tetracyclines or Renamycins with oral contraceptives.

Contraindications

Oxytetracycline should not be used with patients who are hypersensitive to Tetracyclines. It should not be used in children under 12 years of age. It is contraindicated in pregnant women because of tooth staining in the fetus and possible growth retardation effects.

Side Effects

Side effects of Renamycin, which have been reported in some patients, are anorexia, nausea, vomiting, diarrhoea, glossitis, skin rashes and urticaria.

Pregnancy & Lactation

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues and can have toxic effects on the developing fetus. Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. Tetracyclines are present in the milk of lactating women who are taking a drug in this class.

Precautions & Warnings

Renamycin should be used with caution in renal impairment.

Therapeutic Class of Oxytetracycline:-

Eye Anti-Infectives & Antiseptics, Tetracycline group of drugs, Topical antibiotics for Acne

Other Preparation Component Of Oxytetracycline:-

1.Oxytetracycline+Polymixin B Sulphate :-

Ointment 1.Polytetra( 3%+0.013% ) 5gm tube (AS A (Oxytetracycline+Polymixin B Sulphate) AS A Topical Antibiotic preparations).

Indications of (Oxytetracycline+Polymixin B Sulphate):-

This is indicated for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline and polymyxin-sensitive organisms, including infections due to streptococci, rickettsiae, E. coli, and A. aerogenes, such as conjunctivitis, keratitis, pink eye, corneal ulcer, blepharitis in dogs, cats, cattle, sheep, and horses; ocular infections due to secondary bacterial complications of distemper in dogs, and bacterial inflammatory conditions which may occur secondary to other infectious diseases in the above species.

Pharmacology

Oxytetracycline inhibits cell growth by inhibiting translation. It binds to the 30S ribosomal subunit and prevents the amino-acyl tRNA from binding to the A site of the ribosome. The binding is reversible in nature. Oxytetracycline is lipophilic and can easily pass through the cell membrane or passively diffuses through porin channels in the bacterial membrane.

The broad-spectrum effectiveness of this ointment against both gram-positive and gram-negative organisms is enhanced by the particular effectiveness of polymyxin B against infections associated with gram-negative organisms, especially those due to Pseudomonas aeruginosa, where polymyxin B is the antibiotic of choice. In addition, there is evidence to indicate that polymyxin B sulfate possesses some antifungal activity.

Dosage & Administration

Oxytetracycline Hydrochloride and Polymyxin B Sulfate Ophthalmic Ointment should be administered topically to the eye 2-4 times daily.

Side Effects

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no common side effects have been reported with Polytetra. Seek medical attention right away if any of these severe side effects occur: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); eye swelling or redness.

Pregnancy & Lactation

If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using oxytetracycline or polymyxin b sulfate ointment while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use oxytetracycline or polymyxin b sulfate ointment, check with your doctor. Discuss any possible risks to your baby.

Precautions & Warnings

Serious, life threatening, hypersensitivity (anaphylactic) reactions have been reported in some cats following application of antibiotic ophthalmic preparations. If your cat has swelling of the face, itching, appears weak, vomits, or has difficulty breathing within 4 hours of application you should discontinue treatment and contact your veterinarian immediately. The use of oxytetracycline and other antibiotics may result in an overgrowth of resistant organisms such as Monilia, staphylococci, and other species of bacteria. If new infections due to nonsensitive bacteria or fungi appear during therapy, appropriate measures should be taken.

Therapeutic Class of (Oxytetracycline+Polymixin B Sulphate):-

Topical Antibiotic preparations

5.Tetracycline Hydrochloride(Oral):-

Capsule 1.Tetrasina 250 mg (AS A Tetracycline Hydrochloride AS A Tetracycline group of drugs).

Capsule 2.Tetrasina 500 mg (AS A Tetracycline Hydrochloride AS A Tetracycline group of drugs).

Indications of Tetracycline Hydrochloride(Oral):-

Tetrasina is the drug of choice in the following infections :

Ricketsial infection (Rocky Mountain spotted fever, endemic and scrub typhus fever and human ehrlichiosis).
Mycoplasma pneumoniae infections in adults. Outbreaks of pneumonia caused by this organism are common in barracks and institutions. Most cases occur in children and young adults. Maculopapular rashes, haemolytic anaemia and meningo-encephalitis occur rarely.
Chlamydial Infections: Chlamydia psittaci: This organism is the cause of psittacosis (ornithosis), a systemic illness contracted from infected birds. The pneumonia associated with it may be extensive, and severe systemic upset and death are common.Headache is a prominent early symptom.
Non-gonococcal or non specific urethritis: Inflammation of the urethra not resulting from gonococcal, chlamydial, or other specific infectious agents.
Lyme disease
Brucellosis
Miscellaneous infections, including granuloma inguinale, cholera, glanders, relapsing fever and V. vulnifians.

Other common uses of tetracycline include the following:

Urinary Tract Infections with susceptible organisms (including the acute urethral syndrome in women).
Bronchitis in patients with known underlying chronic lung diseases.
Pelvic inflammatory disease and other sexually transmitted diseases (STDs) regimen.
Travelers diarrhoea.
Acne vulgaris
Prostatitis.
As an alternative agent in the penicillin allergic patient with syphilis.
Anaerobic infections with susceptible organisms.

Pharmacology

Tetracycline has its main mechanism of action on protein synthesis, and an energy-dependent active transport system pumps the drug through the inner cytoplasmic membrane of bacteria. Once inside the bacterial cell, Tetracycline binds specifically to the 30s ribosomes and inhibit bacterial protein synthesis.

Many Gram positive aerobic Cocci are susceptible, but many strains of staphylococci, streptococci and even some pneumococci are resistant to Tetracycline. Thus, tetracycline is not the drug of choice in infections due to gram positive aerobes.

Pseudomonas and many Enterobacteriaceae are resistant. Urinary concentrations are adequate for some community – acquired E. coli and consequently, Tetracycline is still used in uncomplicated initial UTIs. Tetracycline is also active against and is the drug of choice for Brucella species, Calymmatobacterium granulomatis, Vibrio cholerae and V. vulnificus.

Tetracycline is also active against anaerobic species of bacteria and since concentrations of the drug are quite high in the gastrointestinal contents, the enteric flora are usually altered by the drug.

Tetracycline is incompletely absorbed from the gastro-intestinal tract, about 60 to 80% of a dose of tetracycline usually being available. It is widely distributed through the body tissues and fluids.

Tetracycline has a half-life of about 12 hours. It is excreted in the urine and in the faeces.

Dosage & Administration

The usual adult oral dosage of Tetracycline is 1-2 g daily given in 2-4 divided doses. The usual oral dosage of Tetracycline for children older than 8 years of age in 25-50 mg/kg daily given in 2-4 divided doses. Alternatively some clinicians recommended that children should receive 0.6-1.2 g/m2 daily.

Tetracycline should be taken preferably one hour before or 2 hours after meals.

Some specific indications along with some information on dosage is given below:

Acne vulgaris: 250 mg four times daily or 500 mg 12 hourly for 1 week; 125-250 mg for several weeks or months. Duration of therapy is determined by individual progress

Acute staphylococcal infections: 1-2 g daily in divided doses for 10-14 days

Acute streptococcal infections: 1-2 g daily in divided doses for 10 days. Prolonged therapy is needed to avoid risk of rheumatic fever or glomerulonephritis

Amoebiasis: 1 g daily in four divided doses or 500 mg 12 hourly for 7 days. Given in association with amoebicidal agents

Brucellosis: 500 mg four times daily plus 1 g streptomycin twice daily for 1 week ; then 500 mg four times daily (no streptomycin) for 1 week. Prolonged therapy is necessary to avoid relapse

Subacute bacterial endocarditis: 1-2 g daily in divided doses for 6 weeks. Usually given in combination with a bactericidal agent

Syphilis: Total 30-40 g given in divided doses over 10-15 days. Serology and spinal fluid examination should follow the administration of tetracycline.

Interaction

Impaired absorption with antacids containing divalent and trivalent cations (e.g. Al, Ca, Mg), Fe, Zn and Na bicarbonate preparations, kaolin-pectin, bismuth subsalicylate, sucralfate, strontium ranelate, colestipol and colestyramine. May interfere with the bactericidal action of penicillin. May potentiate the effect of anticoagulants. May decrease efficacy of oral contraceptives. Nephrotoxic effects may be exacerbated by diuretics or other nephrotoxic drugs. May increase the hypoglycaemic effect of insulin and sulfonylureas in patients with DM. May increase toxic effects of ergot alkaloids and methotrexate.

Contraindications

Tetracycline Hydrochloride is contraindicated in patients hypersensitive to any of the member of tetracycline groups, since cross-sensitivity may occur Tetracycline Hydrochloride should be avoided in patients with systemic lupus erythematosus. Tetracycline Hydrochloride is considered to be contraindicated in renal impairment, particularly if severe ; if it must be given, doses should be reduced.

Side Effects

Teeth and bone: Tetrasina can cause depression of bone growth, permanent graybrown discoloration of the teeth and enamel hypoplasia when given during tooth development (i.e. during the later half of pregnancy, during infancy and in childhood).

Hypersensitivity reactions such as anaphylaxis, urticaria and rashes are uncommon. Photosensitivity reactions consisting of a red rash on areas exposed to intense sunlight can occur with Tetrasina.

Gastrointestinal effects: Epigastric distress and nausea are commonly seen after oral administration, and these symptoms are somewhat dose related. Vomiting can occur.

Accentuated prerenal azotemia: Tetrasina appears to aggravate pre-existing renal failure by inhibiting protein synthesis, which increases the azotemia from amino acid metabolism.

Superinfections with oral and anogenital candidiasis are relatively common in patients taking Tetrasina.

Esophageal ulcerations: In most cases, the patients were taking the capsules with little or no fluid before going to bed. To help minimize this, oral doses should be given with adequate amounts of fluid.

Pregnancy & Lactation

Tetracycline should not be used during pregnancy because of the risk of hypertoxicity in the mother as well as the effects on the developing foetus. Use in pregnancy potentially during breast-feeding and in children up to the age of 8, or some authorise say 12 years, may result in impaired bone growth and permanent discoloration of the child’s teeth.

Precautions & Warnings

Care should be taken if Tetrasina is given to patients with impaired liver function and high doses should be avoided. Potentiality hepatotoxic drugs (including erythromycin, chloramphenicol, isoniazide and sulphonamides) should not be given concomitantly.

Therapeutic Class Tetracycline Hydrochloride(Oral):-

Tetracycline group of drugs

Other Component Preparation of Tetracycline Hydrochloride :-

Tetracycline Hydrochloride(Ophthalmic):-
1. Tetracycline Hydrochloride (Topical):-

1.Tetracycline Hydrochloride(Ophthalmic):-

Ophthalmic Ointment 1. A-Tetra 1% 5gm Tube (AS A Tetracycline Hydrochloride AS A Ophthalmic antibacterial drugs).

Indications of Tetracycline Hydrochloride(Ophthalmic):-

A-Tetra ointment is indicated as followings-

Treatment of bacterial conjunctivitis
Treatment of trachoma (by preference use oral azithromycin for this indication)
Prevention of chlamydial and gonococcal neonatal conjunctivitis

Pharmacology

Tetracycline exhibits its bacteriostatic action by reversibly binding to the 30S subunits of the ribosome, thus preventing protein synthesis and arresting cell growth. It has a broad spectrum of antimicrobial activity including Chlamydiaceae, Mycoplasma spp., Rickettsia spp., spirochaetes, many aerobic and anaerobic gm+ve and gm-ve pathogenic bacteria and some protozoa.

Dosage & Administration

Wash the eyes with boiled and cooled water before each application. Use sterile sodium chloride 0.9% for newborns. Apply tetracycline 1% into the conjunctival sac of both eyes:

Conjunctivitis: one application 2 times daily for 7 days
Trachoma: one application 2 times daily for 6 weeks
Prevention of neonatal conjunctivitis: one single application immediately after birth

Interaction

Contraindications

Do not use in patients with hypersensitivity to tetracyclines. May cause allergic reactions; stop treatment in the event of a serious reaction.

Side Effects

Burning, irritation, visual disturbances, superinfections, photosensitivity, hypersensitivity

Pregnancy & Lactation

Pregnancy Category- D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Precautions & Warnings

Hepatic impairment. Avoid exposure to sunlight. Periodic evaluation of renal, hepatic and haematological system during prolonged therapy.

Therapeutic Class of Tetracycline Hydrochloride(Ophthalmic):-

Ophthalmic antibacterial drugs

2.Tetracycline Hydrochloride (Topical):- Null.

6.Tigecycline:-

IV Infusion 1.Widebac 50mg/Vial 50 mg Vial (AS A Tigecycline AS A Tetracycline group of drugs).

Indications of Tigecycline:-

Widebac IV Infusion is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below:

Complicated Skin and Skin structure Infections: Complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, Enterobacter cloacae, Klebsiella pneumoniae and Bacteroides fragilis.

Complicated Intra-Abdominal Infections: Complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros.

Community-Acquired Bacterial Pneumonia: Community-acquired bacterial pneumonia caused by Streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative isolates), and Legionella pneumophila.

Description

Widebac is a glycylcycline antibacterial agent for intravenous infusion. Widebac inhibits protein translation in bacteria by binding to the 30S ribosomal subunit and blocking entry of amino-acyl tRNA molecules into the A site of the ribosome. This prevents incorporation of amino acid residues into elongating peptide chains. To date there has been no cross-resistance observed between Widebac and other antibacterials.

Pharmacology

Tigecycline, a glycylcycline, inhibits protein translation in bacteria by binding to the 30S ribosomal subunit and blocking entry of amino-acyl tRNA molecules into the A site of the ribosome. This prevents incorporation of amino acid residues into elongating peptide chains. Tigecycline carries a glycylamido moiety attached to the 9-position of minocycline. The substitution pattern is not present in any naturally occurring or semisynthetic tetracycline and imparts certain microbiologic properties to tigecycline. Tigecycline is not affected by the two major tetracycline resistance mechanisms, ribosomal protection and efflux. Accordingly, tigecycline has demonstrated in vitro and in vivo activity against a broad spectrum of bacterial pathogens. There has been no cross resistance observed between tigecycline and other antibiotics. Tigecycline is not affected by resistance mechanisms such as beta-lactamases (including extended spectrum beta-lactamases), target site modifications, macrolide efflux pumps or enzyme target changes (e.g. gyrase/topoisomerase). In vitro studies have not demonstrated antagonism between tigecycline and other commonly used antibacterial drugs. In general, tigecycline is considered bacteriostatic.

Dosage & Administration

The duration of therapy should be guided by the severity and site of the infection and the patient’s clinical and bacteriological progress. The recommended duration of treatment with Tigecycline for complicated skin and skin structure infections or for complicated intra-abdominal infections is 5 to 14 days and for community-acquired bacterial pneumonia is 7 to 14 days. The recommended daily dose is as follows:

Adults: The recommended dosage regimen for Tigecycline is an initial dose of 100 mg, followed by 50 mg every 12 hours. Intravenous (IV) infusions of Tigecycline should be administered over approximately 30 to 60 minutes every 12 hours.

Pediatric use: Safety and effectiveness in pediatric patients below the age of 18 years have not been established.

Geriatric use: No unexpected overall differences in safety or effectiveness were observed between these subjects and younger subjects.

Interaction

Drug interaction of Widebac with Digoxin and Warfarin is observed.

Contraindications

Tigecycline is contraindicated in patients with known hypersensitivety to any components of this product.

Side Effects

The most common treatment-emergent adverse events are nausea and vomiting which generally occurre during the first 1-2 days of therapy. The following drug-related adverse events are reported infrequently in patients receiving Widebac: Injection site inflammation & pain, septic shock, allergic reaction, chills, thrombophlebitis, bradycardia, tachycardia, vasodilatation, anorexia, dry mouth, hypoglycemia, hyponatremia, prolonged prothrombin time, eosinophilia, thrombocytopenia, vaginal moniliasis, vaginitis, leukorrhea.

Pregnancy & Lactation

Tigecycline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Tigecycline is administered to a nursing woman.

Precautions & Warnings

Widebac is structurally similar to Tetracycline-class antibiotics and should be administered with caution in patients with known hypersensitivity to Tetracycline-class antibiotics.

Overdose Effects

No specific information is available on the treatment of overdosage with Widebac. Intravenous administration of Widebac at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting.

Therapeutic Class of Tigecycline:-

Tetracycline group of drugs

Raiyyan Tahsan Date:28-01-2025 Tuesday Time:11-49-45 Pm