Antibiotic Case No 12. Macrolides Class Drug.

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Antibiotic Case No 12. Macrolides Class Drug.

(Includes Tablet,Capsule,Syrup,IV Infusion,Pediatrics Drop,Injection,Cream,Ointmentc,Eye Drop,Eye Ointment,Ear Drop,Vaginal Tablet,Lotion)

1.Azithromycin Dihydrate(Oral):-

2. Azithromycin Dihydrate(Ophthalmic):-

3.Chloramphenicol (Ophthalmic).

4. Chloramphenicol(Oral).

5.Clarithromycin.

6.Clindamycin (Oral).

7. Clindamycin (Lotion).

8. Clindamycin(Vaginal Cream).

9.Erythromycin (Oral).

10.Fusidic Acid.

11.Linezolid.

12.Roxithromycin.

13.Spectinomycin.

14.Spiramycin.

Descriptition:-

1.Azithromycin Dihydrate(Oral):-

Tablet 1.Zimex 500 mg (AS A Azithromycin Dihydrate AS A Macrolides).

Capsule 2.Zimex 250 mg (AS A Azithromycin Dihydrate AS A Macrolides).

Syrup 3. Zimex 200mg/5ml 15,30,50 ml Bottle. (AS A Azithromycin Dihydrate AS A Macrolides).

IV Infusion 4. Zimex 500mg/vial (AS A Azithromycin Dihydrate AS A Macrolides).

Indications of Azithromycin Dihydrate:-

Zimax is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. In sexually transmitted diseases in men and women, Zimax is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.

Pharmacology of Azithromycin Dihydrate:-

Azithromycin is acid-stable and can therefore be taken orally with no need of protection from gastric acids. It is readily absorbed; its absorption is greater on an empty stomach. Time to peak concentration in adults is 2.1 to 3.2 hours for oral dosage forms. Due to the high concentration in phagocytes, azithromycin is actively transported to the site of infection. During active phagocytosis, large concentrations of azithromycin are released. The concentration of azithromycin in the tissues can be over 50 times higher than in plasma. This is due to ion trapping and the high lipid solubility.

Azithromycin’s half-life allows a large single dose to be administered and yet maintain bacteriostatic levels in the infected tissue for several days. Following a single 500 mg dose, plasma concentrations of azithromycin declined in a polyphasic pattern with a mean apparent plasma clearance of 630 mL/min and a terminal elimination half life of 68 hours. The prolonged terminal half-life is thought to be due to extensive uptake and subsequent release of drug from tissues. Biliary excretion of azithromycin, predominantly unchanged, is a major route of elimination. Over the course of a week, approximately 6% of the administered dose appears as unchanged drug in urine.

Microbiology: Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and, thus, interfering with microbial protein synthesis. Nucleic acid synthesis is not affected. Azithromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections:

Aerobic and facultative gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
Aerobic and facultative gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae
Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis , Mycoplasma pneumoniae , Betalactamase production should have no effect on azithromycin activity.
Aerobic and facultative gram-positive microorganisms: Streptococci (Groups C,F,G), Viridans group streptococci
Aerobic and facultative gram-negative microorganisms: Bordetella pertussis, Legionella pneumophila
Anaerobic microorganisms: Peptostreptococcus species, Prevotella bivia

Dosage of Azithromycin Dihydrate:-

Oral–
Adult: 500 mg once daily orally for 3 days or 500 mg once on day 1, then 250 mg once on days 2-5 for 4 days. For sexually transmitted diseases caused by Chlamydia trachomatis in adults, the dose is 1 gm given as a single dose or 500 mg once on day 1, followed by 250 mg once daily for next 2 days may also be given.

Children:

10 mg/kg body weight once daily for 3 days for child over 6 months
200 mg (1 teaspoonful) for 3 days if body weight is 15-25 kg
300 mg (1½ teaspoonfuls) for 3 days if body weight is 26-35 kg; 400 mg (2 teaspoonfuls) for 3 days if body weight is 36-45 kg.
In typhoid fever, 500 mg (2½ teaspoonfuls) once daily for 7-10 days is given.

Azithromycin Injection (For IV Infusion only): The recommended dose of Azithromycin for injection for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is:

500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7 to 10-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response.
The recommended dose of Azithromycin for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by Azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy. The timing of the switch to oral therapy should be done at the discretion of the physician and in accordance with clinical response. If anaerobic microorganisms are suspected of contributing to the infection, an antimicrobial agent with anaerobic activity should be administered in combination with Azithromycin.
Safety and effectiveness of azithromycin for injection in children or adolescents under 16 years have not been established.

Administration of Azithromycin Dihydrate:-

Reconstitution procedure of suspension-

Step 01: Shake the bottle well to loosen the powder.
Step 02: Add boiled and cooled water up to the water mark of the bottle label.
Step 03: Shake until powder is completely mixed with water.

Azithromycin should be taken at least 1 hour before or 2 hours after meal.

Interaction of Azithromycin Dihydrate:-

Antacid: In patients receiving azithromycin and antacids, azithromycin should be taken at least 1 hour before or 2 hours after the antacid. Carbamazepine: In a pharmacokinetic interaction study in healthy volunteers, no significant effect was observed on the plasma levels of carbamazepine or its active metabolite.

Cyclosporin: Some of the related macrolide antibiotics interfere with the metabolism of cyclosporin. In the absence of conclusive data from pharmacokinetic studies or clinical data investigating potential interactions between azithromycin and cyclosporine, caution should be exercised before co-administration of these two drugs. If coadministrations is necessary, cyclosporin levels should be monitored and the dose adjusted accordingly.

Digoxin: Some of the macrolide antibiotics have been reported to impair the metabolism of digoxin (in the gut) in some patients. Therefore, in patients receiving concomitant azithromycin and digoxin the possibility of raised digoxin levels should be borne in mind and digoxin levels monitored.

Ergot derivatives: Because of the theoretical possibility of ergotism, azithromycin and ergot derivatives should not be co-administered.

Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, azithromycin had no significant effect on the pharmacokinetics of methylprednisolone.

Theophylline: There is no evidence of any pharmacokinetic interaction when azithromycin and theophylline are co-administered to healthy volunteers. In general, however, theophylline levels should be monitored.

Warfarin: In a pharmacodynamic interaction study, azithromycin did not alter the anticoagulant effect of a single 15 mg dose of warfarin administered to healthy volunteers. Zimax and warfarin may be co-administered, but monitoring of the prothrombin time should be continued as routinely performed.

Terfenadine: Zimax did not affect the pharmacokinetics of terfenadine administered at the recommended dose of 60 mg every 12 hours. Addition of azithromycin did not result in any significant changes in cardiac repolarisation (QTc interval) measured during the steady state dosing of terfenadine.

Contraindications of Azithromycin Dihydrate:-

Azithromycin Dihydrate is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.

Side Effects of Azithromycin Dihydrate:-

Zimax is well tolerated with a low incidence of side-effects. Most side-effects observed were mild to moderate in severity. The majority of side-effects were gastrointestinal in origin with nauseas, abdominal discomfort (pain/cramps), vomiting, flatulence, diarrhoea and loose stools being occasionally observed. Allergic reactions such as rash or photosensitivity have occurred and there have also been rare reports of serious hypersensitivity reactions. Reversible elevations in liver transaminases have been seen with a frequency similar to the comparative macrolides and penicillins used in clinical trials. Rarely, cases of cholestatic jaundice have been observed. Transient mild reductions in neutrofil counts have occasionally been observed in clinical trials, although a causal relationship to azithromycin has not been established. Hearing impairment: In investigational studies where higher doses were used for prolonged periods of time, reversible hearing impairment was seen in some patients.

Pregnancy & Lactation of Azithromycin Dihydrate:-

Pregnancy Category of Azithromycin Dihydrate is B. Animal reproduction studies have demonstrated that Azithromycin has no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available. It is not known whether Azithromycin is secreted in breast milk. So, caution should be exercised when Azithromycin is administered to nursing women.

Precautions & Warnings of Azithromycin Dihydrate:-

As with erythromycin and other macrolides, rare serious allergic reactions, including angioneurotic oedema and anaphylaxis, has been reported. Some of these reactions with azithromycin have resulted in recurrent symptoms and required a long period of observation and treatment.

Use in Special Populations

Use in renal impairment: No dose adjustment is needed in patients with mild renal impairment (creatinine clearance >40 ml/min), but there are no data regarding azithromycin in patients with more severe renal impairment, thus caution should be exercised in using azithromycin in these patients.

Use in hepatic impairment: As the liver is the principal route of excretion of azithromycin, it should not be used in patients with hepatic disease.

Effects on ability to drive and use machines: There is no evidence to suggest that azithromycin may have an effect on a patient’s ability to drive or operate machinery.

Overdose Effects of Azithromycin Dihydrate:-

There is no data on overdosage with Zimax. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.

Storage Conditions of Azithromycin Dihydrate:-

Keep in a dry place away from light and heat. Keep out of the reach of children.

Other Component Or Preparation of Azithromycin Dihydrate:-

1.Azithromycin Dihydrate(Ophthalmic):-

Eye Drop 1.Zibac 1% 2.5ml Drop (AS A Azithromycin Dihydrate AS A Macrolides).

Indications of Azithromycin Dihydrate:-

Zibac Eye Drops is indicated for the treatment of bacterial conjunctivitis caused by CDC coryneform group G, Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumonia.

2. Azithromycin Dihydrate(Ophthalmic):-

Eye Drop 1.Zibac 1% 2.5ml Drop (AS A Azithromycin Dihydrate AS A Macrolides).

Indications of Azithromycin Dihydrate:-

3.Chloramphenicol (Ophthalmic):-

Indications of Chloramphenicol (Ophthalmic):-

Chloramphenicol is indicated for the treatment of ocular infections involving the conjunctiva and/or cornea caused by chloramphenicol-susceptible organisms. Such as Staphylococcus aureus, Streptococcus pneumoniae, E.coli, H. influenzae, Klebsiella/Enterobacter spp, Moraxella lacunata, and Neisseria species.

Pharmacology of Chloramphenicol (Ophthalmic):-

Chloramphenicol is a broad-spectrum bacteriostatic antibiotic which acts through the inhibition of bacterial protein synthesis by interfering with the transfer of activated amino acids from soluble RNA to ribosomes.

Dosage & Administration of Chloramphenicol (Ophthalmic):-

Adult and Children: Instill 1 or 2 drops in the conjunctival sac 4-6 times per day for the first 72 hours and then every 4 hours thereafter. Treatment should be continued for approximately 7 days, but should not be continued for more than 3 weeks without re-evaluation by the physician.

Interaction of Chloramphenicol (Ophthalmic):-

Chymotrypsin may be inhibited if given simultaneously with Chloramphenicol.

Contraindications

It is contraindicated in individuals with a history of hypersensitivity to Chloramphenicol or any ingredients of the preparation.

Side Effects of Chloramphenicol (Ophthalmic):-

The systemic adverse reaction has not been observed within short-term topical use of Chloramphenicol. The most frequently reported adverse reactions have been burning, stinging, conjunctival hyperemia, blood dyscrasia, allergic or inflammatory reactions, vesicular and maculopapular dermatitis.

Pregnancy & Lactation of Chloramphenicol (Ophthalmic):-

Safety for use in pregnancy and lactation has not been established. Therefore, use only when considered essential by the physicians.

Precautions & Warnings

Chloramphenicol ophthalmic solution should never be given for minor infections or for prophylaxis. Repeated course and prolonged treatment should be avoided. Blood dyscrasias (granulocytopenia, thrombocytopenia and moderate anaemia) may occur after prolonged ophthalmic use.

Overdose Effects

Accidental ingestion of the medicine is unlikely to cause any toxicity due to low content of antibiotic.

Therapeutic Class of Chloramphenicol (Ophthalmic):-

Ear Anti-Infectives & Antiseptics, Eye Anti-Infectives & Antiseptics, Macrolides

Eye Ointment 1.Conicol 1% 3gm tube (AS A Chloramphenicol AS A Ear Anti-Infectives & Antiseptics, Eye Anti-Infectives & Antiseptics, Macrolides).

Eye Drop/Ear 2. Conicol 0.5% 10ml Drop (AS A Chloramphenicol AS A Ear Anti-Infectives & Antiseptics, Eye Anti-Infectives & Antiseptics, Macrolides).

Indications of Chloramphenicol (Ophthalmic):-

Conicol is indicated for the treatment of ocular infections involving the conjunctiva and/or cornea caused by Conicol-susceptible organisms. Such as Staphylococcus aureus, Streptococcus pneumoniae, E.coli, H. influenzae, Klebsiella/Enterobacter spp, Moraxella lacunata, and Neisseria species.

Other Preparation Of Chloramphenicol (Ophthalmic):- Main Class

1.Beclomethasone Dipropionate +Chloramphenicol+Clotrimazole+Lidocaine.

2. Chloramphenicol(Oral).

3.Dexamethasone + Chloramphenicol.

4. Chloramphenicol+ Lidocaine Hydrochloride.

Descriptition:-

1.Beclomethasone Dipropionate +Chloramphenicol+Clotrimazole+Lidocaine:-(M)

Ear Drop 1.Candibac (0.025%+5%+1%+1.73%) 5ml Drop (AS A Beclomethasone Dipropionate +Chloramphenicol+Clotrimazole+Lidocaine) (AS A Anti-fungal or anti-bacterial ear drops).

Indications of Ear Drop 1.Candibac (0.025%+5%+1%+1.73%) 5ml Drop (AS A Beclomethasone Dipropionate +Chloramphenicol+Clotrimazole+Lidocaine) (AS A Anti-fungal or anti-bacterial ear drops).

Formidable combination for ear infections-

Safe and effective combination in otitis externa & otitis media with the perforated ear.
Shows higher efficacy of Clotrimazole to treat Otomycosis.
Shows excellent pain reduction of lidocaine to treat acute otitis media.

2. Chloramphenicol(Oral):- :-(M)

Capsule 1.Chlorool 250 mg (AS A Chloramphenicol AS A Macrolides).

Syrup 2. Chlorool 125mg/5ml 60ml Bottle AS A (AS A Chloramphenicol AS A Macrolides).

Indications of Capsule 1.Chlorool 250 mg (AS A Chloramphenicol AS A Macrolides).

Chlorool is an antibiotic that is clinically useful for, and should be reserved for, serious infections caused by organisms susceptible to its antimicrobial effects when less potentially hazardous therapeutic agents are ineffective or contraindicated. However, Chlorool may be chosen to initiate antibiotic therapy on the clinical impression that one of the conditions below is believed to be present. In vitro sensitivity tests should be performed concurrently so that the drug may be discontinued as soon as possible if less potentially dangerous agents are indicated by such tests. The decision to continue use of Chlorool, rather than another antibiotic when both are suggested by in vitro studies to be effective against a specific pathogen, should be based upon severity of the infection, susceptibility of the pathogen to the various antimicrobial drugs, and the efficacy of the various drugs in the infection

3.Dexamethasone + Chloramphenicol:- :-(M)

Indications of Dexamethasone + Chloramphenicol:-

Eye: This combination is indicated in acute purulent conjunctivitis, fresh inflammation of the superficial and deeper corneal layers and corneal ulceration. It is also used in keratitis disciformis and the more deep-seated forms of post-herpetic keratitis, allergic conjunctivitis, allergic blepharitis, acute and chronic iritis, chronic anterior uveitis and corneal injury from chemical radiation or thermal burns, or penetration of foreign bodies. The combination is used in steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or arisk of bacterial ocular infection exists. The combination can also be used for post-operative inflammation and any other ocular inflammation associated with infection.

Ear: This combination is indicated in otitis externa, otitis media and chronic suppurative otitis media.

Pharmacology of Dexamethasone + Chloramphenicol:-

Dexamethasone is a glucocorticoid. It has an anti-inflammatory and anti-allergic action. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye. Dexamethasone is absorbed rapidly after oral administration with a half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects.

Chloramphenicol is a broad spectrum bacteriostatic antibiotic active against a wide variety of gram-negative and gram-positive organisms. Chloramphenicol exerts its antibacterial effect by binding to bacterial ribosomes and inhibiting bacterial protein synthesis at an early stage

Dosage & Administration of Dexamethasone + Chloramphenicol:-

Eye:

Bacterial Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is 1 to 2 drops instilled into the conjunctival sac (s) every 2 hours for 2 days and 1 or 2 drops every 4 hours for the next 5(five days) while awake.
Corneal Ulcers: The recommended dosage regimen for the treatment of comeal ulcer is 2 drops in the affected eye (s) every 15 minutes for the first 6 hours then 2 drops into the affected eye(s) every 30 minutes for the remainder of first day. On the second day, instill 2 drops in the affected eye (s) hourly. On the 3 to 14 days, place 2 drops in the affected eye (s) every 4 hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.

Ear: For all infections, 2 to 3 drops every 2 to 3 hours initially. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely.

Interaction of Dexamethasone + Chloramphenicol:-

If Chloramphenicol is absorbed from eye when taking anticoagulants e.g. warfarin, there may be an increase in the effect of this medicine. Action of Chloramphenicol will be inhibited if given simultaneously with Phenobarbital. The therapeutic efficacy of Dexamethasone may be reduced with the concomitant administration of phenytoin, phenobarbitone, ephedrine and rifampicin.

Contraindications of Dexamethasone + Chloramphenicol:-

The combination is contraindicated in epithelial herpes simplex cornealis, fungal, viral, tuberculous and other infections of the eye and in glaucoma. Myelosuppression during previous exposure to Chloramphenicol. Hypersensitivity to Chloramphenicol & Dexamethasone Phosphate or to any other ingredients of the preparations.

Side Effects of Dexamethasone + Chloramphenicol:-

Adverse reactions seen with Chloramphenicol are transient ocular burning or discomfort and other reported reactions include stinging, redness, itching, conjunctivitis, foreign body sensation, photophobia, blurred vision, dryness and eye pain. Allergic sensitization may occur with the local use of Chloramphenicol. Elevation of intraocular pressure with possible development of glaucoma, infrequent optic nerve damage and posterior subcapsular cataract formation.

Pregnancy & Lactation of Dexamethasone + Chloramphenicol:-

There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Chloramphenicol and Dexamethasone ophthalmic solution is administered to a nursing mother.

Precautions & Warnings

The possibility of persistent fungal infections of the cornea should be considered after prolonged corticosteroid dosing. Prolonged use of steroids containing products may result in posterior subcapsular cataract formation and glaucoma with optic nerve damage. Intraocular pressure monitoring is needed. Prolonged use of antibiotics may result in the overgrowth of non-susceptible organisms, including fungi. If new infections appear during treatment, the drug should be discontinued and alternative therapy should be instituted.

Therapeutic Class of Dexamethasone + Chloramphenicol:-

Ophthalmic steroid – antibiotic combined preparations

Eye/Ear Drop 1.Dexaguard (0.1%+0.5%) 5ml Drop (AS A Dexamethasone + Chloramphenicol AS A Ophthalmic steroid – antibiotic combined preparations).

Indications of Eye/Ear Drop 1.Dexaguard (0.1%+0.5%) 5ml Drop (AS A Dexamethasone + Chloramphenicol AS A Ophthalmic steroid – antibiotic combined preparations).

Eye: Dexaguard is indicated in acute purulent conjunctivitis, fresh inflammation of the superficial and deeper corneal layers and corneal ulceration. It is also used in keratitis disciformis and the more deep-seated forms of post-herpetic keratitis, allergic conjunctivitis, allergic blepharitis, acute and chronic iritis, chronic anterior uveitis and corneal injury from chemical radiation or thermal burns, or penetration of foreign bodies. The combination is used in steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or arisk of bacterial ocular infection exists. The combination can also be used for post-operative inflammation and any other ocular inflammation associated with infection.

Ear: Dexaguard is indicated in otitis externa, otitis media and chronic suppurative otitis media.

Dexamethasone Other Preparation :-Sub Class

1.Calcium Dobesilate+Lidocaine+Dexamethasone.

2.Dexamethasone(Oral).

3. Dexamethasone+Levofloxacin.

4. Dexamethasone+Tobramycin.

5.Moxifloxacin Hydrochloride+ Dexamethasone.

6.Ciprofloxacin+ Dexamethasone

7. Dexamethasone(Ophthalmic).

8. Dexamethasone+Neomycin Sulphate+Polymyxin-B-sulphate.

9.Gatifloxacin+ Dexamethasone.

1.Calcium Dobesilate+Lidocaine+Dexamethasone:- Sub Class

Indications of 1.Calcium Dobesilate+Lidocaine+Dexamethasone:- Sub Class

This rectal ointment is indicated in-

Internal and external hemorrhoids
Anal pruritus
Anal eczema
Anitis
Perianitis
Acute hemorrhoidal thrombosis
Anal fissure
Pre and postoperative treatment in cases of hemorrhoidectomy

A long-lasting treatment is not indicated.

Rectal Ointment 1.Dobecil LD (4%+2%+0.025%) 30 gm tubeAS A Calcium Dobesilate+Lidocaine+Dexamethasone AS A Drugs used in Ano-rectal region.

2.Dexamethasone (Oral):- :- Sub Class

Tablet 1.Decason 0.5mg/6mg (AS A Dexamethasone AS A synthetic glucocorticoid).

Injection 2. Decason IM/IV 6mg/ ml 1ml Ampoule (AS A Dexamethasone AS A synthetic glucocorticoid).

Indications of Dexamethasone:-

Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis and serum sickness.
Collagen disease: Like lupus erythematosus, rheumatoid arthritis etc.
Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus and severe erythema multiforme (Stevens-Johnson syndrome).
Endocrine disorders: Primary or secondary adrenocortical insufficiency, congenital adrenal hyperplasia, hypercalcemia associated with cancer and nonsuppurative thyroiditis.
Gastrointestinal diseases: Regional enteritis and ulcerative colitis.
Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults and selected cases of secondary thrombocytopenia.
Neoplastic diseases: Leukemias and lymphomas.
Nervous system: Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury.
Ophthalmic diseases: Temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
Renal diseases: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.
Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.
Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.
Miscellaneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.

3. Dexamethasone+Levofloxacin:- :- Sub Class

Eye Drop 1.Trevox-D (0.1%+0.5%) 5ml Drop (AS A (Dexamethasone+Levofloxacin ) AS A Macrolides).

Indications of Dexamethasone+Levofloxacin:-

This combination ophthalmic solution is indicated for prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults.

4. Dexamethasone+Tobramycin:- :- Sub Class

Indications of Dexamethasone+Tobramycin:-

This preparation is indicated for steroid responsive inflammatory ocular conditions (palpebral and bulbar conjunctiva, cornea and anterior segment of the globe) where superficial bacterial ocular infection exists. It is also indicated in chronic anterior uveities and corneal injury from chemical radiation or thermal burns, or penetration of foreign bodies. The use of combination with an anti-infective component is indicated where the risk of superficial ocular infection is high.

Eye Ointment 1.T-Mycin Plus (0.1%+0.3%) 3.5gm tube (AS A . (Dexamethasone+Tobramycin)AS A Ophthalmic steroid – antibiotic combined preparations.)

Eye Drop 2. T-Mycin Plus (0.1%+0.3%) 5ml drop (AS A . (Dexamethasone+Tobramycin)AS A Ophthalmic steroid – antibiotic combined preparations.)

5.Moxifloxacin Hydrochloride+ Dexamethasone:- Sub Class

Indications of Moxifloxacin Hydrochloride+ Dexamethasone:-

Moxifloxacin & Dexamethasone eye drop is indicated in the treatment of eye infections caused by susceptible microorganisms and in the prevention of inflammation and bacterial infection that may occur after eye surgery.

Eye Drop 1.Iventi-D (0.5%+0.1%) 5ml Drop AS A (Moxifloxacin Hydrochloride+ Dexamethasone) (AS A Ophthalmic Steroid preparations).

Only Moxifloxacin (Ophthalmic):- Sub Class

Indications of Moxifloxacin Hydrochloride (Ophthalmic):-

Moxifloxacin Hydrochloride ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:

Aerobic Gram-positive microorganisms: Corynebacterium species, Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumoniae, Streptococcus viridans group.
Aerobic Gram-negative microorganisms: Acinetobacterlwoffii, Haemophilusinfluenzae, Haemophilus parainfluenzae.
Other microorganisms: Chlamydia trachomatis.

Intraocular injection: A highly effective Intraocular Antibiotic to prevent Postoperative Bacterial Endophthalmitis.

Eye Drop 1. Iventi 0.5% 5ml Drop (AS A Moxifloxacin Hydrochloride AS A Ophthalmic antibacterial drugs).

Moxifloxacin Other component Preparation (Ophthalmic):- Sub Class

1.Moxifloxacin Hydrochloride+Xanthan Gum:- Sub Class

Eye Drop 1.Moxquin –XG (0.5%+0.4%) 5ml Drop AS A (Moxifloxacin Hydrochloride+Xanthan Gum)AS A Ophthalmic antibacterial drugs.

Indications of Moxifloxacin Hydrochloride+Xanthan Gum:-

This ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms-

Aerobic Gram-positive microorganisms: Corynebacterium species, Micrococcus luteus, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus warneri, Streptococcus pneumonia, Streptococcus viridans group.

Aerobic Gram-negative microorganisms: Acinetobacter iwoffii, Haemophilus influenza, Haemophilus parainfluenzae.

6.Ciprofloxacin+ Dexamethasone:- Sub Class

Indications of (Ciprofloxacin+ Dexamethasone):-

Eye: This is indicated for the treatment of steroid responsive inflammatory ocular conditions where bacterial infections or risk of bacterial infections co-exist. The combination can also be used for post-operative inflammation and any other ocular inflammation associated with infection.

Ear: This is also indicated in the treatment of ear infections accompanied by inflammation such as otitis externa, acute and chronic otitis media etc. The combination may also be used post-operatively in the ear.

Eye/Ear Drop 1:-Beuflox –D (0.3%+0.1%) 5ml drop (AS A (Ciprofloxacin+ Dexamethasone) AS A Aural steroid & antibiotic combined preparations).

Only Ciprofloxacin Ophrthalmic Preparation:- :- Sub Class

Eye Ointment 1.Aprocin 0.3% 3gm tube (AS A Ciprofloxacin AS A Aural Anti-bacterial preparations, Ophthalmic antibacterial drugs)

Eye Drop 2. Aprocin 0.3% 10 ml drop (AS A Ciprofloxacin AS A Aural Anti-bacterial preparations, Ophthalmic antibacterial drugs)

Indications of (Ciprofloxacin Ophrthalmic Preparation):-

Aprocin 0.3% ophthalmic solution is indicated for the treatment of corneal ulcers, conjunctivitis, and blepharitis, which are caused by susceptible strains of bacteria.

Ciprofloxacin Other Preparation :- :- Sub Class

1.Ciprofloxacin +Hydrocortisone Acetate:- :- Sub Class

Indications of (Ciprofloxacin +Hydrocortisone Acetate):-

This ophthalmic suspension is indicated for the treatment of acute otitis externa in adult and paediatric patients due to susceptible strains of Pseudomonas Aeruginosa, Staphylococcus aureus and Proteus mirabilis.

Eye Drop 1.Ciprocort (0.3%+1%) 10 ml Drop (AS A Ciprofloxacin +Hydrocortisone Acetate AS A Aural steroid & antibiotic combined preparations).

7. Dexamethasone(Ophthalmic):- Sub Class

Indications of Dexamethasone(Ophthalmic):-

Dexamethasone ophthalmic solution or ointment is indicated for the treatment of

Allergic non-infectious blepharitis and conjunctivitis
Non-infectious keratitis, punctate keratitis, disciform keratitis (provided the corneal surface is intact)
Inflammation of the anterior uvea (iritis, iridocyclitis )
Scleritis, episcleritis and myositis
Post-operative management of cataract, strabismus & other ocular surgeries.

Eye Ointment 1:-Sonexa 0.05% 3gm tube AS A Dexamethasone AS A Corticosteroids

Eye Drop 2. Sonexa 0.1% 5ml Drop AS A A Dexamethasone AS A Corticosteroids.

8. Dexamethasone+Neomycin Sulphate+Polymyxin-B-sulphate:- Sub Class

Indications of (Dexamethasone+Neomycin Sulphate+Polymyxin-B-sulphate):-

This preparation is indicated for the short term treatment of steroid responsive conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of fungal and viral disease.

Eye Drop 1.Neo-DP (1mg+3500IU+6000IU)/ml 5ml drop AS A (Dexamethasone+Neomycin Sulphate+Polymyxin-B-sulphate).(AS A Ophthalmic steroid – antibiotic combined preparations).

9.Gatifloxacin+ Dexamethasone:- :- Sub Class

Indications of (Gatifloxacin+ Dexamethasone):- Sub Class

This preparation is indicated for steroid responsive infammatory conditions with involvement of bacteria; such as- Blepharitis, Scleritis, Episcleritis, Iritis, Cyclitis, Iridocyclitis, Choroiditis, Optic neuritis and chronic anterior uveitis. Also useful in disciform and interstitial keratitis, allergic corneal marginal ulcers, corneal injury from chemical radiation or thermal burns.

Eye Drop 1.Orbidex – G (0.3%+0.1%) 5ml Drop (As a (Gatifloxacin+ Dexamethasone) AS A Ophthalmic steroid – antibiotic combined preparations).

Gatifloxacin Other Preparation:- Sub Class

Only Gatifloxacin:- Sub Class

Eye Drop 1.Gatiflox ES 0.5% 5ml Drop (AS A Gatifloxacin AS A Ophthalmic antibacterial drugs).

Indications of Gatifloxacin:-

Gatiflox ES eye drops is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:

Aerobic Gram-Positive Bacteria:

Corynebacterium propinquum
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus mitis
Streptococcus pneumoniae

Aerobic Gram-Negative Bacteria:

Haemophilus influenzae.

Other Gatifloxacin Preparation :- Sub Class

1.Loteprednol Etabonate +Gatifloxacin:- Sub Class

Eye Drop 1.Lotepro – G (0.5%+0.3% ) (AS A (Loteprednol Etabonate +Gatifloxacin ) AS A Ophthalmic Steroid preparations).

Indications of (Loteprednol Etabonate +Gatifloxacin):-

This ophthalmic suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne, superficial punctate keratitis, herpes zoster keratitis, iritis, and cyclitis. It is also indicated for the treatment of post-operative inflammation following ocular surgery.

4. Chloramphenicol+ Lidocaine Hydrochloride. :-(M)

Ear Drop 1.Chlorphen (5%+1%) 10ml Drop AS A (Chloramphenicol+ Lidocaine Hydrochloride) (AS A Aural Anti-bacterial preparations).

Indications of (Chloramphenicol+ Lidocaine Hydrochloride):-

Acute bacterial ear infections

4. Chloramphenicol(Oral). :-(M)

Indications of Chloramphenicol:-

Chloramphenicol is an antibiotic that is clinically useful for, and should be reserved for, serious infections caused by organisms susceptible to its antimicrobial effects when less potentially hazardous therapeutic agents are ineffective or contraindicated. However, chloramphenicol may be chosen to initiate antibiotic therapy on the clinical impression that one of the conditions below is believed to be present. In vitro sensitivity tests should be performed concurrently so that the drug may be discontinued as soon as possible if less potentially dangerous agents are indicated by such tests. The decision to continue use of chloramphenicol, rather than another antibiotic when both are suggested by in vitro studies to be effective against a specific pathogen, should be based upon severity of the infection, susceptibility of the pathogen to the various antimicrobial drugs, and the efficacy of the various drugs in the infection

Capsule 1.Chlorool 250mg,(AS A Chloramphenicol AS A Macrolides).

Syrup 2. Chlorool 125mg/5ml ,(AS A Chloramphenicol AS A Macrolides).

5.Clarithromycin:- :-(M)

Indications of Clarithromycin:-

Clarithromycin is indicated for the treatment of-

Acute bacterial exacerbation of chronic bronchitis in adults
Acute maxillary sinusitis
Community-acquired pneumonia
Pharyngitis or tonsillitis
Uncomplicated skin and skin structure infections
Acute otitis media in pediatric patients
Treatment and prophylaxis of disseminated mycobacterial infections
Helicobacter pylori infection and duodenal ulcer disease in adults

Tablet 1.Clarimax 500mg/250 mg (AS A Clarithromycin AS A Macrolides).

Syrup 2. Clarimax 125mg/5ml (AS A Clarithromycin AS A Macrolides).

6.Clindamycin (Oral):- :-(M)

Indications of Clindamycin:-

Clindamycin has been shown to be effective in the treatment of the following infections when caused by susceptible anaerobic bacteria or susceptible strains of gram positive bacteria such as Streptococci, Staphylococci and Pneumococci; Upper respiratory infections, Lower respiratory infections, Skin and soft tissue infections, Bone and joint infections, Pelvic infections, Intra-abdominal infections, Septicemia and endocarditis, Dental infections. As an alternative therapy when used in combination with quinine or amodiaquine for the treatment of multi-drug resistant Plasmodium falciporum infection.

Description of Clindamycin:-

Clindamycin is a lincosamide antibiotic used in the treatment of infections caused by susceptible microorganisms. Clindamycin is a semisynthetic antibiotic derived from lincomycin.

Aerobic gram-positive cocci, including: Staphylococcus aureus, Staphylococcus epidermidis (penicillinase and non-penicillinase producing strains), Streptococci, Pneumococci.

Anaerobic gram-negative bacilli, including: Bacteroides species, Fusobacterium species.

Anaerobic gram-positive non-spore forming bacilli, including: Propionibacterium species, Eubacterium species, Actinomyces species.

Anaerobic and microaerophilic gram-positive cocci, including: Peptococcus species, Peptostreptococcus species, Microaerophilic streptococci, C. perferinges

Capsule 1.Cinamycin 150mg/300mg (AS A Clindamycin AS A Macrolides).

Injection 2. Cinamycin IM/IV 300mg/2ml and 600mg/4ml (AS A Clindamycin AS A Macrolides).

Syrup 3.Clindacin 75mg/5ml 100ml Bottle. (AS A Clindamycin AS A Macrolides).

7. Clindamycin (Lotion):- :-(M)

Indications of Clindamycin (Lotion):-

Clindamycin lotion is indicated in the treatment of acne vulgaris. Other uses of topical Clindamycin lotion are:

Skin infections such as erythrasma caused by Corynebacterium minutissimum; rosacea, periorificial dermatitis, folliculitis, stasis, chronic lymphaedema and familial pemphigus.
Dermal ulcers.

Lotion 1.Clindacin 1% 25ml Bottle (AS A Clindamycin AS A Macrolides).

Other Component Or Preparation of Clindamycin :-

1.Clindamycin +Benzoyl Peroxide

2.Clindamycin+Tretinoin

1.Clindamycin +Benzoyl Peroxide:-

Topical Gel 1:-Clindax –B (1%+5%) 10/20 gm tube (AS A Clindamycin +Benzoyl Peroxide) (AS A Benzoyl peroxide, Azelaic acid & other preparations).

Indications of (Clindamycin +Benzoyl Peroxide):-

This gel is for cutaneous use only. This is indicated for the topical treatment of mild to moderate acne vulgaris, particularly inflammatory lesions, in adults and adolescents aged 12 years and above.

2.Clindamycin+Tretinoin:-

Topcal Gel:-1.Lindamax Plus (1.2%+0.025%) 10gm tube (AS A ( Clindamycin+Tretinoin) AS A Topical antibiotic & retinoid preparations)

Indications of (Clindamycin+Tretinoin):-

Clindamycin and Tretinoin gel is indicated for the topical treatment of Acne vulgaris.

8. Clindamycin(Vaginal Cream):- :-(M)

Indications of (Clindamycin(Vaginal Cream):-

Clindamycin cream is indicated in the treatment of bacterial vaginosis. Clindamycin cream can be used to treat non pregnant women and pregnant women during the second and third trimester.

Vaginal Cream 1:Clindacin 2% 20gm tube (AS A Clindamycin AS A Macrolides).

9.Erythromycin (Oral). :-(M)

Indications of Erythromycin (Oral):-

Erythromycin is highly effective in the treatment of a wide variety of clinical infections.

Upper respiratory tract infections: Tonsilitis, Peritonsillar abscess, Pharyngitis, laryngitis, Sinusitis. Secondary infections in colds and influenza.
Lower respiratory tract infections: Tracheitis, acute and chronic bronchitis.
Ear infections: Otitis media, otitis externa, mastoiditis.
Eye infections: Blepharitis, established trachoma.
Skin and Soft tissue infections: Boils and carbuncles, impetigo, abscesses, pustular acne, paromychia, cellulitis, erysipelas.
Gastrointestinal tract infections: Cholecystitis, staphylococcal enterocolitis.
Prophylaxis: Pre and post-operative, trauma, burns, rheumatic fever.
Other infections: Osteomyelitis, diptheria, scarlet fever, whooping cough.

Description Erythromycin (Oral):-

Erythromycin belongs to the macrolides group of antibiotics. It exerts a bacteriostatic or bactericidal action based on specific interference with ribosomal protein synthesis within the bacterial cell. THROCIN is mainly used for the treatment of infections caused by penicillinase producing staphylococci. The following micro-organisms are particularly susceptible to Erythromycin. Gram (+)ve : Cocci and bacilli. Gram (-)ve : Neisseria catarhalis, N.meningitis, N.gonorrhoea, Haemophilus influenzae, Brodetella, H. pertussis.Other micro-organisms : Mycoplasma pneumoniae, Legionella pneumophila, Bacteroides fragilis, B.oralis, B.melaninogenicus, Fusobacterium, Chlamydia trachomatis, Treponema pallidum.

Tablet 1.Firmac 250mg/500 mg (AS A Erythromycin AS A Anti-diarrhoeal Antimicrobial drugs, Macrolides).

Syrup 2.Firmac 125mg/5ml 100ml Bottle (AS A Erythromycin AS A Anti-diarrhoeal Antimicrobial drugs, Macrolides).

Pediatric Drop 3.A-Mycin 200mg/5ml 60ml Bottle (AS A Erythromycin AS A Anti-diarrhoeal Antimicrobial drugs, Macrolides).

Erythromycin Other Component Preparation:- :-(M)

Erythromycin (Lotion) 1.Eromycin 3% 25ml Bottle (AS A Erythromycin AS A Topical antibiotics for Acne).

10.Fusidic Acid:- :-(M)

Indications of Fusidic Acid:-

Fusidic Acid is indicated for the topical treatment of superficial bacterial infections of the eye and its adnexa. These may include – bacterial conjunctivitis, blepharoconjunctivitis, blepharitis, sty and keratitis. It may also be used for the management of corneal and conjunctival abrasions and foreign body injuries.

Eye Drop 1.Fusithal ( Viscous) 1% 5gm tube (AS A Fusidic Acid AS A Macrolides).

Fusidic Acid Other Preparation:-

1.Fusidic Acid+Betamethasone

2.Fusidic Acid+Hydrocortisone

1.Fusidic Acid+Betamethasone :- :- Sub Class

Indications of (Fusidic Acid+Betamethasone):-

This combination cream is indicated in eczema and dermatitis with secondary infections including atopic dermatitis, allergic and seborrhoeic dermatitis and primary irritant dermatitis.

Cream 1.Facid BT (2%+0.1%) 10gm Tube (AS A Fusidic Acid+Betamethasone AS A Other Topical corticosteroids).

2.Fusidic Acid+Hydrocortisone:- Sub Class

Indications of (Fusidic Acid+Hydrocortisone):-

This preparation is indicated in the following skin diseases where bacterial infections are already present or suspected to occur-

Primary irritant dermatitis
Contact allergic dermatitis
Eczema (atopic, infantile, discoid, stasis)
Seborrhoeic dermatitis

Cream 1.Fortison (2%+1%) 10gm Tube (AS A (Fusidic Acid+Hydrocortisone) AS A Hydrocortisone & Combined preparations).

11.Linezolid:- :-(M)

Indications of (Linezolid):-

Linezolid is indicated for the treatment of:

Nosocomial pneumonia
Community-acquired pneumonia
Complicated skin and skin structure infection including diabetic foot infections, without concomitant osteomyelitis
Uncomplicated skin and skin structure infections
Vancomycin-resistant Enterococcus faecium infections

Limitations of use: Linezolid is not indicated for the treatment of Gram-negative infections. The safety and efficacy of Linezolid given for longer than 28 days have not been evaluated in controlled clinical trials.

Tablet 1.Linzolid 400/600mg (AS A Linezolid AS A Macrolides).

Syrup 2.Linzolid 100mg/5ml 100 ml Bottle (AS A Linezolid AS A Macrolides).

IV Infusion 3. Linzolid 2mg/5ml 300ml/100ml Solution (AS A Linezolid AS A Macrolides).

12.Roxithromycin:- :- :-(M)

Indications of Roxithromycin:-

Roxithromycin is indicated in the treatment of infections caused by susceptible microorganisms-

Respiratory infections like pneumonia, acute and chronic bronchitis, and bronchopneumonia
ENT infections like tonsillitis, pharyngitis, sinusitis and otitis media.
Skin infections like folliculitis, furuncles, cellulitis, carbuncles, pyoderma, impetigo and infected dermatitis.
Genital infections like urethritis, prostatitis, cervicitis and salpingitis especially if produced by Chlamydia trachomatis.

Description of Roxithromycin:-

Roxithromycin, is a macrolide with antibacterial properties similar to erythromycin. It is active against Gram-positive bacteria like staphylococci, streptococci, listeria, corynebacteria; Gram-negative bacteria such as gonococci, Haemophilus influenzae, Haemophilus ducreyi, Legionella, campylobacter, and atypical pathogens like Mycoplasma and Chlamydia. Roxithromycin has been found useful in the treatment of upper and lower respiratory tract infection, otorhinolaryngological, skin, dental and genital infections. It is well tolerated by adults and children.

Tablet 1.Pedilid 150mg/300mg (AS A Roxithromycin AS A Macrolides).

Syrup 2. Pedilid 50mg/5ml 50ml Bottle (AS A Roxithromycin AS A Macrolides).

13.Spectinomycin:- :-(M)

Indications of Spectinomycin:-

Spectinomycin Sterile Powder is indicated in the treatment of:

Acute gonorrheal urethritis and proctitis in the male
Acute gonorrheal cervicitis and proctitis in the female
Men and women with known recent exposure to gonorrhea should be treated as those known to have gonorrhea.

Injection 1.Tinobac IM Injection 2gm/Vial (AS A Spectinomycin AS A Macrolides).

14.Spiramycin:- :-(M)

Indications of Spiramycin:-

Spiramycin is indicated for the treatment of infections of the respiratory tract, buccal cavity, skin and soft tissues due to susceptible organisms. Neisseria gonorrhoeae: as an alternate choice of treatment for gonorrhea in patients allergic to the penicillins. Before treatment of gonorrhea, the possibility of concomitant infection due to T. pallidum should be excluded.

Description of Spiramycin:-

Spiramycin is a macrolide antibiotic produced by Streptomyces ambofaciens. It is active against the following Gram-positive organisms: Staphylococcus aureus (including penicillin resistant strains), ß-haemolytic streptococci, Streptococcus viridans, Streptococcus faecalis and Streptococcus pneumoniae, Corynebacterium diphteriae, clostridia. Except for Bordetella pertussis, Hemophilus influenzae (approximately 50% of strains) and neisseria, gram-negative organisms are generally considered as resistant to spiramycin. Bacterial resistance to spiramycin has been reported to develop, including cross-resistance between spiramycin and erythromycin. However, most of the erythromycin-resistant strains of S. aureus are still sensitive to spiramycin.

Tablet 1.Rovamycine 3MIU (AS A Spiramycin AS A Macrolides).

Raiyyan Tahsan Date:30-01-2025 Thursday Time:11-28-55 Pm