Clobet GM

Clobet GM also contains the following ingredients: Methyl paraben 1.8 mg, propyl paraben 0.2 mg, sodium bisulfite 3.2 mg, disodium ethylenediaminetetraacetate 0.1 mg and water for injection.

Clobet GM sulfate injection is a sterile solution of Clobet GM sulfate water for injection. It contains the equivalent of not less than 90% and not more than 125% of the labeled amount of Clobet GM. It may contain suitable buffers, preservatives, sequestering agents, unless it is intended for intrathecal use, in which case it contains only suitable tonicity agents.

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

Clobet GM Sulfate Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the following microorganisms: Pseudomonas aeruginosa, Proteus species (indole-positive and indole-negative), Escherichia coli, Klebsiella-Enterobacter-Serratia species, Citrobacter species, and Staphylococcus species (coagulase-positive and coagulase-negative).

Clinical studies have shown Clobet GM Sulfate Injection, USP to be effective in bacterial neonatal sepsis; bacterial septicemia; and serious bacterial infections of the central nervous system (meningitis), urinary tract, respiratory tract, gastrointestinal tract (including peritonitis), skin, bone and soft tissue (including burns).

Aminoglycosides, including Clobet GM, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are susceptible to these antibiotics and are not susceptible to antibiotics having less potential for toxicity.

Specimens for bacterial culture should be obtained to isolate and identify causative organisms and to determine their susceptibility to Clobet GM.

Clobet GM Sulfate may be considered as initial therapy in suspected or confirmed gram-negative infections, and therapy may be instituted before obtaining results of susceptibility testing. The decision to continue therapy with this drug should be based on the results of susceptibility tests, the severity of the infection, and the important additional concepts contained in the box. If the causative organisms are resistant to Clobet GM, other appropriate therapy should be instituted.

In serious infections when the causative organisms are unknown, Clobet GM Sulfate may be administered as initial therapy in conjunction with a penicillin-type or cephalosporin-type drug before obtaining results of susceptibility testing. If anaerobic organisms are suspected as etiologic agents, consideration should be given to using other suitable antimicrobial therapy in conjunction with Clobet GM. Following identification of the organism and its susceptibility, appropriate antibiotic therapy should then be continued.

Clobet GM Sulfate has been used effectively in combination with carbenicillin for the treatment of life-threatening infections caused by Pseudomonas aeruginosa. It has also been found effective when used in conjunction with a penicillin-type drug for the treatment of endocarditis caused by group D streptococci.

Clobet GM Sulfate Injection, USP has also been shown to be effective in the treatment of serious staphylococcal infections. While not the antibiotic of first choice, Clobet GM may be considered when penicillins or other less potentially toxic drugs are contraindicated and bacterial susceptibility tests and clinical judgment indicate its use. It may also be considered in mixed infections caused by susceptible strains of staphylococci and gram-negative organisms.

In the neonate with suspected bacterial sepsis or staphylococcal pneumonia, a penicillin-type drug is also usually indicated as concomitant therapy with Clobet GM.

Clobet GM is an antibiotic. It fights bacteria in the body.

Clobet GM is used to treat severe or serious bacterial infections.

Clobet GM may also be used for purposes other than those listed in this medication guide.

Each ampoule is for use in a single patient on 1 occasion only.

Adults: Serious Infections (Systemic and Urinary Tract Infections): 3 mg/kg/day in 3 doses given every 8 hrs.

Life-Threatening Infections: Up to 5 mg/kg/day in 3 or 4 equal doses with reduction to 3 mg/kg/day as soon as clinically indicated. Doses should never exceed 5 mg/kg/day unless serum levels are monitored.

The following table should be used as a guide: See Table 1.

Children: The following table should be used as a guide: See Table 2.

Patients with Renal Impairment: Dosage should be adjusted to minimise the risk of toxicity. The 1st dose should be as normal eg, 80 mg (body weight >60 kg) and subsequent doses should be given less frequently, depending on the degree of renal impairment.

Table 3 should be used as a guide: See Table 3.

When only a serum urea concentration is available, this value may be utilized initially, however, it should be supplemented with a serum creatinine level or creatinine clearance rate whenever possible.

Note: The standard dose of 80 mg 3 times a day may be inappropriate and a more appropriate dose can be calculated using a nomogram which takes into account the patient's serum creatinine levels, body weight and age. This dose can be adjusted if necessary following determination of serum creatinine levels. Desirable serum levels of Clobet GM are 5-8 mcg/mL as a peak and 1-2 mcg/mL as a trough.

Note: In children with impaired renal function, serum levels should be monitored and frequency of dosage reduced if indicated.

Adults with Renal Failure Undergoing

Haemodialysis:

Administration: Clobet GM is normally given by IM injection.

Intravenous administration may be used for particular indications when the IM route is not appropriate. The dosage is the same for either route of administration. It is desirable to measure both peak and trough serum levels during treatment. Prior to administration, the patient's body weight should be measured for the correct calculation of dosage. In obese patients, the appropriate dose can be calculated by assuming the body weight is the patient's estimated lean body weight plus 40% of the excess. Blood specimens for the determination of peak Clobet GM concentrations should be obtained approximately 1 hr following IM administration and 30-min after completion of a 30-min infusion. Blood specimens for the trough Clobet GM concentration should be obtained immediately prior to the next IM or IV dose.

Intravenous Administration:

See also:
What is the most important information I should know about Clobet GM?

Known hypersensitivity to Clobet GM or aminoglycosides and/or preserving agents (para group allergy); patients with preexisting vestibular and/or cochlear disease should be given aminoglycosides for life-threatening conditions only.

Administration of other ototoxic and/or nephrotoxic antibiotics together with or immediately after Clobet GM should be avoided.

Caution should be exercised in patients with reduced renal function to avoid drug cumulation. Caution is also indicated in patients with milder degrees of renal insufficiency, neuromuscular disease (eg, myasthenia gravis or Parkinson's disease) and at an advanced age. As Clobet GM contains sulfite, it must not be used in asthmatics hypersensitive to sulfite.

Use in pregnancy & lactation: During pregnancy, Clobet GM should only be given for life-threatening conditions or if other antibiotics are ruled out. As Clobet GM is known to be present in breast milk, breastfeeding should be suspended if Clobet GM is administered during lactation.

Use Clobet GM drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Clobet GM drops is for use in the eye. Avoid contact with other mucous membranes.
• Soft contact lenses may absorb a chemical in Clobet GM drops. Do not wear contact lenses while you are using Clobet GM drops. Take care of your contact lenses as directed by the manufacturer. Check with your doctor before you use them.
• To use Clobet GM drops in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
• To clear up your infection completely, use Clobet GM drops for the full course of treatment. Keep using it even if you feel better in a few days.
• Using Clobet GM drops at the same times each day will help you to remember to use it.
• If you miss a dose of Clobet GM drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Clobet GM drops.

This medication is used to treat minor skin infections (such as impetigo, folliculitis) or minor infections related to some skin conditions (such as eczema, psoriasis, minor burns/cuts/wounds). Clobet GM works by stopping the growth of certain bacteria. It belongs to a class of drugs known as aminoglycoside antibiotics.

This antibiotic only treats bacterial infections. It will not work for virus or fungus infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

How to use Clobet GM topical

This medication is for use on the skin only.

Wash your hands before using. Clean and dry the affected area as directed. If you are treating impetigo, remove any dried, crusty skin to increase contact between the antibiotic and the infected area. Then gently apply a small amount of medication in a thin layer as directed by your doctor, usually 3 to 4 times a day. You may cover the area with a sterile gauze bandage if so directed. Keep the infected area clean. Wash your hands after use, unless you are using this product to treat the hands.

Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wipe off the medication and rinse thoroughly with water.

Dosage and length of treatment is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. Do not apply large amounts of this medication, use it more often, or use it for longer than prescribed. Your condition will not improve any faster, and your risk of side effects may increase.

Continue to use this medication for the full length of treatment prescribed, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection.

Tell your doctor if your skin infection persists or if it worsens.

See also:
What other drugs will affect Clobet GM?

Penicillins: Clobet GM is inactivated by solutions containing β-lactam antibiotics (penicillins and cephalosporins) so the 2 drugs should not be administered simultaneously nor should they be combined in the IV fluid. The inactivation of Clobet GM by penicillins may occur in vivo, especially in patients with renal failure who maintain a higher level of the penicillin for a longer period of time. Therefore, when Clobet GM and penicillins are used together in patients with renal failure, the time of administration of each drug should be staggered so that several hours separate each infusion.

Diuretics: Potent diuretics eg, ethacrynic acid or frusemide may potentiate the ototoxic effects of Clobet GM.

Other Neurotoxic and/or Nephrotoxic Agents: Since the ototoxic or nephrotoxic effects of Clobet GM may be additive, avoid concurrent or sequential use of other neurotoxic and/or nephrotoxic antibiotics, including other aminoglycosides, polymyxin B, colistin, cisplatin, vancomycin, amphotericin, clindamycin and cephalosporins.

Neuromuscular-Blocking Agents: Respiratory paralysis and prolongation of neuromuscular blockade may occur if a neuromuscular-blocking agent eg, suxamethonium (succinylcholine), tubocurarine, decamethonium, halogenated hydrocarbon inhalation anaesthetics, opioid analgesics or massive transfusions with citrated anticoagulated blood are administered to a patient receiving Clobet GM.

Vitamin K: Clobet GM may inhibit the action of IV vitamin K upon the synthesis of clotting factors.

Potential Interactions: In vitro synergism and antagonism have been found between various antineoplastic agents and aminoglycosides.

Incompatibilities. When Clobet GM is used in combination with any other drug, mixing the drugs before administration should be avoided at all costs.

See also:
What are the possible side effects of Clobet GM?

Nephrotoxicity: Adverse renal effects, as demonstrated by the presence of casts, cells or protein in the urine or by rising BUN, NPN, serum creatinine or oliguria, have been reported. They occur more frequently in patients with a history of renal impairment and in patients treated for longer periods or with larger dosages than recommended.

Neurotoxicity: Serious adverse effects on both vestibular and auditory branches of the eighth nerve have been reported, primarily in patients with renal impairment (especially if dialysis is required) and in patients on high doses and/or prolonged therapy. Symptoms include dizziness, vertigo, tinnitus, roaring in the ears and also hearing loss, which, as with the other aminoglycosides, may be irreversible. Hearing loss is usually manifested initially by diminution of high-tone acuity. Other factors which may increase the risk of toxicity include excessive dosage, dehydration and previous exposure to other ototoxic drugs.

Peripheral neuropathy or encephalopathy, including numbness, skin tingling, muscle twitching, convulsions, and a myasthenia gravis-like syndrome, have been reported.

NOTE: The risk of toxic reactions is low in patients with normal renal function who do not receive Clobet GM Sulfate at higher doses or for longer periods of time than recommended.

Other reported adverse reactions possibly related to Clobet GM include: Respiratory depression, lethargy, confusion, depression, visual disturbances, decreased appetite, weight loss and hypotension and hypertension; rash, itching, urticaria, generalized burning, laryngeal edema, anaphylactoid reactions, fever, and headache; nausea, vomiting, increased salivation, and stomatitis; purpura, pseudotumor cerebri, acute organic brain syndrome, pulmonary fibrosis, alopecia, joint pain, transient hepatomegaly and splenomegaly.

Laboratory abnormalities possibly related to Clobet GM include: Increased levels of serum transaminase (SGOT, SGPT), serum LDH and bilirubin; decreased serum calcium, magnesium, sodium and potassium; anemia, leukopenia, granulocytopenia, transient agranulocytosis, eosinophilia, increased and decreased reticulocyte counts and thrombocytopenia. While clinical laboratory test abnormalities may be isolated findings, they may also be associated with clinically related signs and symptoms. For example, tetany and muscle weakness may be associated with hypomagnesemia, hypocalcemia and hypokalemia.

While local tolerance of Clobet GM Sulfate is generally excellent, there has been an occasional report of pain at the injection site. Subcutaneous atrophy or fat necrosis suggesting local irritation has been reported rarely.