Alclox

Amoxicillin Trihydrate:

• Pharmacological action
• Pharmacokinetics
• Why is Alclox prescribed?
• Dosage and administration
• Alclox (Amoxicillin Trihydrate) side effects, adverse reactions
• Contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Precautionary measures
• Alclox drug interactions
• Alclox in case of emergency / overdose
• Alclox (Amoxicillin Trihydrate) reviews

Pharmacological action

Alclox is an antibiotic of group semisynthetic penicillins a wide spectrum of action. It is a 4-hydroxyl analog of ampicillin. It has bactericidal action. Alclox (Amoxicillin Trihydrate) is active against aerobic gram-positive bacteria: Staphylococcus spp. (except strains producing penicillinase), Streptococcus spp; aerobic gram-negative bacteria: Neisseria Gonorrhoeae, Neisseria Meningitidis, Escherichia Coli, Shigella spp., Salmonella spp., Klebsiella spp.

Microorganisms producing penicillinase is resistant to Alclox (Amoxicillin Trihydrate).

In combination with metronidazole Alclox (Amoxicillin Trihydrate) is active against Helicobacter Pylori. It is believed that inhibits the development of Alclox (Amoxicillin Trihydrate) resistance of Helicobacter pylori to metronidazole.

There is a cross-resistance between amoxycillin and ampicillin.

The spectrum of antibacterial action while expanding the application of Alclox (Amoxicillin Trihydrate) and beta-lactamase inhibitor clavulanic acid. This combination increased the activity of Alclox (Amoxicillin Trihydrate) against Bacteroides spp., Legionella spp., Nocardia spp., Pseudomonas (Burkholderia) Pseudomallei. However, Pseudomonas Aeruginosa, Serratia Marcescens, and many other gram-bacteria are resistant.

Pharmacokinetics

When Alclox (Amoxicillin Trihydrate) administered orally Alclox (Amoxicillin Trihydrate) rapidly and completely absorbed from the gastrointestinal tract and is not destroyed in the acidic environment of the stomach. C_max of Alclox (Amoxicillin Trihydrate) in the blood plasma is reached after 1-2 h. When increasing doses of 2 times the concentration also increased by 2 times. In the presence of food in the stomach does not reduce the overall removals. Similar concentrations of Alclox (Amoxicillin Trihydrate) reached in the blood when administered orally, IV and IM.

The binding of Alclox (Amoxicillin Trihydrate) to plasma proteins is about 20%.

Widely distributed in tissues and body fluids. Reported high concentrations of Alclox (Amoxicillin Trihydrate) in the liver.

T1/2 from the plasma is 1-1.5 h. About 60% of the dose adopted by mouth, is excreted unchanged in the urine by glomerular filtration and tubular secretion, with a dose of 250 mg of Alclox (Amoxicillin Trihydrate) concentration in urine exceeds 300 micrograms / ml. A number of Alclox (Amoxicillin Trihydrate) is determined in feces.

T1/2 for Newborns and the elderly can be longer.

In renal insufficiency T1/2 may be 7-20 hours.

In small quantities Alclox (Amoxicillin Trihydrate) penetrates through BBB in inflammation of the pia mater.

Alclox (Amoxicillin Trihydrate) is removed by hemodialysis.

Why is Alclox prescribed?

For use Alclox (Amoxicillin Trihydrate) as monotherapy and in combination with clavulanic acid: an infectious-inflammatory diseases caused by susceptible microorganisms, including bronchitis, pneumonia, tonsillitis, pyelonephritis, urethritis, infections of the gastrointestinal tract, gynecological infections, infections of the skin and soft tissue, listeria, leptospirosis, gonorrhea.

For use Alclox (Amoxicillin Trihydrate) in combination with metronidazole: chronic gastritis in acute, peptic ulcer and duodenal ulcer in acute, associated with Helicobacter Pylori.

Dosage and administration

Individual. For oral single dose for adults and children over 10 years is 250-500 mg, in case of serious illness - up to 1 g. For children aged 5-10 years, a single dose of 250 mg in age from 2 to 5 years - 125 mg for children aged under 2 years of daily dose is 20 mg / kg. For adults and children interval is 8 h. In the treatment of acute uncomplicated gonorrhea - 3 g once (in combination with probenecid). Patients with impaired renal function in creatinine clearance 10-40 ml / min interval between doses should be increased to 12 h and if creatinine clearance is less than 10 ml / min interval between doses should be 24 hours.

When parenteral use in adults IM - 1 g 2 times / day, IV (with normal renal function) - 2.12 g / day. Children IM 50 mg / kg / day, single dose - 500 mg, the frequency of administration - 2 times / day; IV - 100-200 mg / kg / day. Patients with impaired renal function the dose and the interval between the injections need to be adjusted in accordance with the values of creatinine clearance.

Alclox (Amoxicillin Trihydrate) side effects, adverse reactions

Allergic reactions: urticaria, erythema, edema Quincke, rhinitis, conjunctivitis, rarely - fever, joint pain, eosinophilia, in rare cases - anaphylactic shock.

Side effects associated with chemotherapy effect: possible development of super-infection (particularly in patients with chronic diseases or low resistance of the organism).

With prolonged use at high doses: dizziness, ataxia, confusion, depression, peripheral neuropathy, seizures.

Mostly when Alclox (Amoxicillin Trihydrate) used in combination with metronidazole: nausea, vomiting, anorexia, diarrhea, constipation, epigastric pain, glossitis, stomatitis; rarely - hepatitis, pseudomembranous colitis, allergic reactions (urticaria, angioedema), interstitial nephritis, a violation of hematopoiesis.

Mostly when Alclox (Amoxicillin Trihydrate) used in combination with clavulanic acid: cholestatic jaundice, hepatitis, rarely - erythema multiforme, toxic epidermal necrolysis, exfoliative dermatitis.

Contraindications

Infectious mononucleosis, lymphatic leukemia, severe gastrointestinal infections, accompanied by diarrhea or vomiting, respiratory viral infection, allergic diathesis, bronchial asthma, hay fever, sensitivity to penicillin and / or cephalosporins.

For use in combination with metronidazole: diseases of the nervous system; hemodyscrasia, lymphocytic leukemia, an infectious mononucleosis; Hypersensitivity to nitroimidazole derivatives.

For use in combination with clavulanic acid: a history of instructions for liver problems and jaundice, associated with the reception of Alclox in combination with clavulanic acid.

Using during pregnancy and breastfeeding

Alclox (Amoxicillin Trihydrate) crosses the placenta, in small amounts excreted in breast milk.

If necessary the use of Alclox (Amoxicillin Trihydrate) during pregnancy should carefully weigh the potential benefits of therapy for the mother and the potential risk to the fetus.

With careful use Alclox (Amoxicillin Trihydrate) during lactation (breastfeeding).

Special instructions

With caution used in patients prone to allergic reactions.

Alclox in combination with metronidazole is not recommended to use in patients younger than 18 years should not be used for liver diseases.

In the combined therapy with metronidazole is recommended not to drink alcohol.

Precautionary measures

Treatment must continue 48-72 hours after the disappearance of clinical signs of disease, with streptococcal infections - 10 days.

During the course treatment is necessary to control the state functions of hematopoiesis, liver and kidneys.

Perhaps the development of superinfection due to growth insensitive to the drug microflora. In the case of superinfection requires removal of Alclox (Amoxicillin Trihydrate) and the corresponding change in antibiotic therapy. When treating patients with bacteremia may develop bacteriolysis reaction (reaction of Jarisch-Herxheimer).

Patients who have an increased sensitivity to penicillin, may be cross-allergic reactions to cephalosporin antibiotics.

In the treatment of mild diarrhea at the background of the treatment should be avoided antidiarrhoeal drugs that reduce intestinal motility; can use kaolin or attapulgite containing antidiarrhoeal stuff. Patients with severe diarrhea should consult a doctor.

With simultaneous use of Alclox (Amoxicillin Trihydrate) and oral contraceptives estrogensoderzhaschih and Alclox (Amoxicillin Trihydrate) should if possible to use additional methods of contraception.

Alclox drug interactions

Alclox (Amoxicillin Trihydrate) may decrease the effectiveness of contraceptives for oral administration.

With the simultaneous use of Alclox (Amoxicillin Trihydrate) with bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) appears synergies; with bacteriostatic antibiotic (including macrolides, chloramphenicol, lincosamides, tetracyclines, sulphonamide) - antagonism.

Alclox (Amoxicillin Trihydrate) increases the effects of indirect anticoagulants inhibiting intestinal microflora, reduces the synthesis of vitamin K and prothrombin index.

Alclox (Amoxicillin Trihydrate) reduces the effect of drugs, in the process of metabolism that produce PABA.

Probenecid, diuretics, allopurinol, phenylbutazone, NSAIDs decrease the tubular secretion of Alclox (Amoxicillin Trihydrate), which can be accompanied by an increase in its concentration in blood plasma.

Antacids, glucosamine, laxatives, aminoglycosides, slow down and reduce, and ascorbic acid increases the absorption of Alclox (Amoxicillin Trihydrate).

With the combined use of Alclox (Amoxicillin Trihydrate) and clavulanic acid pharmacokinetics of both components unchanged.

Alclox in case of emergency / overdose

Symptoms: nausea, vomiting, diarrhea, disruption of water and electrolyte balance (as a result of vomiting and diarrhea); for prolonged use at high doses - neurotoxic reactions and thrombocytopenia (these phenomena are reversible and disappear after drug withdrawal).

Treatment: gastric lavage, the prescription of activated charcoal, saline laxatives, correction of water and electrolyte balance; hemodialysis.

Cloxacillin Sodium:

• Caution:
• Description:
• Storage:
• Action:
• Indications:
• Dosage for dry cows:
• Directions for use:
• Precautions:
• Residue warnings:
• How supplied:
• Alclox (Cloxacillin Sodium) reviews

NADA 055-058, Approved by FDA

Caution:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description:

Alclox (Cloxacillin Sodium) (cloxacillin benzathine) for Intramammary Infusion into the Dry Cow is a product which provides bactericidal activity against gram-positive bacteria. The active agent, Alclox (Cloxacillin Sodium) benzathine, is a sparingly soluble salt of the semisynthetic penicillin, Alclox (Cloxacillin Sodium). Alclox (Cloxacillin Sodium) is a derivative of 6-aminopenicillanic acid, and therefore is chemically related to other penicillins. It has, however, the antibacterial properties described below, which distinguish it from certain other penicillins.

Each 10 mL disposable syringe contains Alclox (Cloxacillin Sodium) benzathine equivalent to 500 mg of Alclox (Cloxacillin Sodium) activity in a stable peanut oil gel. This product was manufactured by a non-sterilizing process.

Storage:

Do not store above 25°C (77°F). Do not freeze.

Action:

In the non-lactating mammary gland, Alclox (Cloxacillin Sodium) (cloxacillin benzathine) provides bactericidal levels of the active antibiotic, Alclox (Cloxacillin Sodium), for a prolonged period of time. This prolonged activity is due to the low solubility of the Alclox (Cloxacillin Sodium) benzathine and to the slow-release oil-gel base. This prolonged contact between the antibiotic and the pathogenic organism enhances the probability of a bacteriological cure.

Alclox (Cloxacillin Sodium) is not destroyed by the enzyme, penicillinase, and therefore, is active against penicillin-resistant strains of Staphylococcus aureus. It is also active against non-penicillinase-producing Staphylococcus aureus as well as Streptococcus agalactiae.

The class disc, Methicillin 5 mcg, should be used to estimate the in vitro susceptibility of bacteria to Alclox (Cloxacillin Sodium).

Indications:

For the treatment of mastitis in dairy cows during the dry period.

Alclox (Cloxacillin Sodium) has been shown by extensive clinical studies to be efficacious in the treatment of mastitis in dry cows, when caused by Streptococcus agalactiae and Staphylococcus aureus including penicillin-resistant strains.

Treatment of the dry cow with Alclox (Cloxacillin Sodium) is indicated in any cow known to harbor any of these organisms in the udder at drying off, or which has had repeated attacks of mastitis during the previous lactation, or is affected with mastitis at drying off, if caused by susceptible organisms.

Dosage for Dry Cows:

Infuse the contents of one syringe (10 mL) into each quarter following the last milking. See Directions for Use.

Directions for Use:

Alclox (Cloxacillin Sodium) (cloxacillin benzathine) is for use in dry cows only. Administer immediately after the last milking. Use no later than 30 days prior to calving.

Completely milk out all four quarters. The udder and teats should be thoroughly washed with warm water containing a suitable dairy antiseptic and dried, preferably using individual paper towels. Carefully scrub the teat end and orifice with 70% alcohol, using a separate swab for each teat. Allow to dry.

Alclox (Cloxacillin Sodium) is packaged with the Opti-Sert^® Protective Cap.

For partial insertion: Twist off upper portion of the Opti-Sert Protective Cap to expose 3–4 mm of the syringe tip.

For full insertion: Remove protective cap to expose the full length of the syringe tip.

Insert syringe tip into the teat canal and expel the entire contents of syringe into the quarter. Withdraw the syringe and gently massage the quarter to distribute the medication.

Do not infuse contents of the mastitis syringe into the teat canal if the Opti-Sert Protective Cap is broken or damaged.

Precautions:

Because it is a derivative of 6-aminopenicillanic acid, Alclox (Cloxacillin Sodium) has the potential for producing allergic reactions. Such reactions are rare; however, should they occur, the subject should be treated with antihistamines or pressor amines, such as epinephrine.

Residue Warnings:

1. For use in dry cows only.

2. Not to be used within 30 days of calving.

3. Any animal infused with this product must not be slaughtered for food until 30 days after the latest infusion.

How Supplied:

Alclox (Cloxacillin Sodium) (cloxacillin benzathine) Intramammary Infusion is supplied as 10 mL syringes containing 500 mg of Alclox (Cloxacillin Sodium) activity per syringe. One display carton contains 12 syringes. One pail contains 144 syringes.

NDC 0010-4720-01 - 10 mL syringe

NDC 0010-4720-02 - 12 syringes

NDC 0010-4720-03 - 144 syringes

Opti-Sert is a registered trademark of Zoetis W LLC - used under license.

Alclox (Cloxacillin Sodium) is a registered trademark of Boehringer Ingelheim Vetmedica, Inc.

© 2014 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved.

Made in Italy

Manufactured for:

Boehringer Ingelheim Vetmedica, Inc.

St. Joseph, MO 64506 U.S.A.

51729292

472001-03