Metro Plus

Metronidazole:

• Pharmacological action
• Pharmacokinetics
• Why is Metro Plus prescribed?
• Dosage and administration
• Metro Plus (Metronidazole) side effects, adverse reactions
• Metro Plus contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• Metro Plus drug interactions
• Metro Plus in case of emergency / overdose
• Metro Plus (Metronidazole) reviews

Pharmacological action

Metro Plus is an anti protozoal agent. It is believed that the mechanism of action is associated with DNA damage-sensitive microorganisms. Active against Trichomonas vaginalis, Gardnerella vaginalis, Giardia lamblia, Entamoeba histolytica, and obligate anaerobic bacteria (including Bacteroides spp., Fusobacterium spp.).

Aerobic bacteria are resistant to Metro Plus (Metronidazole).

In combination with amoxicillin Metro Plus (Metronidazole) is active against Helicobacter pylori. It is believed that amoxicillin inhibits the development of resistance of Helicobacter pylori to Metro Plus (Metronidazole).

Pharmacokinetics

Metro Plus (Metronidazole) well absorbed after oral administration. The bioavailability is 80%. Metro Plus (Metronidazole) is distributed in tissues and body fluids. This medication crosses the placental barrier and the BBB. Binding to plasma proteins is 20%. Metro Plus (Metronidazole) is metabolized in the liver by oxidation and binding to glucuronic acid. T_1/2 is 8 hours. This drug is excreted in the urine (60-80%) and feces (6-15%).

Why is Metro Plus prescribed?

Trichomonazice vaginitis and urethritis in women, trichomonazice urethritis in men, giardiasis, amoebic dysentery, anaerobic infections caused by metronidazole-sensitive organisms, combination therapy of severe mixed aerobic-anaerobic infections. Preventing anaerobic infection in surgery (particularly abdominal, urinary tract). Chronic alcoholism.

Metro Plus (Metronidazole) in combination with amoxicillin: chronic gastritis in acute phase, gastric ulcer and duodenal ulcer in acute phase, associated with Helicobacter pylori.

For external and topical use: treatment of acne vulgaris and pink, bacterial vaginosis, treatment of long-term healing of wounds and trophic ulcers.

Dosage and administration

Metro Plus is administered for oral use for adults and children over 12 years in 7.5 mg / kg every 6 h or 250-750 mg 3-4 times / day. For children up to 12 years the dose is 5-16.7 mg / kg 3 times / day. For IV injections for adults and children over 12 years starting dose is 15 mg / kg, followed by 7.5 mg / kg every 6 hours or depending on the etiology of the disease - by 500-750 mg every 8 hours. The duration of treatment and frequency of tests is determined individually.

Intravaginally - 500 mg 1 time a night.

In combination with amoxicillin (2.25 g / day) daily dose of Metro Plus (Metronidazole) is 1.5 g; multiplicity of admission - 3 times / day. For patients with severe renal impairment (creatinine clearance less than 30 ml / min) and / or liver daily dose of Metro Plus (Metronidazole) is 1 g (amoxicillin - 1.5 g / day), the multiplicity of the reception is 2 times / day. This medication takes for external and local use 2 times / day, doses are determined individually.

The maximum daily dose for adults when taken orally and IV is 4 g.

Metro Plus (Metronidazole) side effects, adverse reactions

Digestive system: nausea, vomiting, anorexia, metallic taste in the mouth.

CNS and peripheral nervous system: headache, nervousness, irritability, insomnia, dizziness, ataxia, weakness, confusion, depression, peripheral neuropathy, seizures, hallucinations.

Allergic reactions: skin rash, itching, hives.

Hemopoietic system: leucopenia.

Local reactions: irritation.

Other: arthralgia, burning sensation in the urethra.

Metro Plus contraindications

Organic CNS lesions, blood diseases, liver problems, I trimester of pregnancy, hypersensitivity to Metro Plus (Metronidazole).

Using during pregnancy and breastfeeding

Metro Plus is rapidly crosses the placental barrier. In II and III trimester of pregnancy Metro Plus (Metronidazole) is used only for health reasons.

Metro Plus (Metronidazole) is excreted in breast milk. If necessary, use during lactation should solve the issue of termination of breastfeeding.

Special instructions

Patients should with careful use of Metro Plus (Metronidazole) in liver diseases.

In combination with amoxicillin this medication is not recommended for patients younger than 18 years. During the treatment period it is necessary the regular control of pattern of peripheral blood.

During the treatment of Trichomonas vaginitis in women and Trichomonas urethritis in men patients should refrain from sexual activity, simultaneous treatment of both partners is mandatory.

During the taking of Metro Plus (Metronidazole) there is a more dark staining of urine.

During treatment with Metro Plus (Metronidazole) should avoid alcohol because to violations of the oxidation of alcohol can accumulate acetaldehyde. As a result may develop reactions similar to those characteristic of disulfiram (abdominal cramps, nausea, vomiting, headache, a sudden rush of blood to the face).

Metro Plus drug interactions

Simultaneous administration of Metro Plus (Metronidazole) with:

Povidone-Iodine:

• Active ingredient
• Purpose
• Use
• Warnings
• Directions
• Other information
• Inactive ingredients
• Metro Plus (Povidone-Iodine) reviews

Active ingredient

Purpose

Antiseptic

Use

Warnings

Do not use

• if allergic to iodine
• in the eyes

Avoid pooling beneath patient

Ask a doctor before use if injuries are

• deep or puncture wounds
• serious burns
  

Stop use and ask a doctor if

• redness, irritation, swelling or pain persists or increases
• infection occurs
  

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Directions

Other information

• 1 percent titratable iodine
• latex free
• for hospital or professional use only
  

Inactive ingredients

citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

1-800-760-3236 (Mon to Fri 8:30 AM-5:00 PM EST)

THREE Metro Plus (Povidone-Iodine) SWABSTICKS

Three 4-inch saturated swabsticks

STERILE unless opened or damaged.

3/4 FLUID OUNCE Metro Plus (Povidone-Iodine) SOLUTION

0.75 Fl. oz. (22.5 mL)

STERILE unless opened or damaged.

Three Metro Plus (Povidone-Iodine) Swabsticks 3/4 Fluid Ounce Metro Plus (Povidone-Iodine) Solution

Total Joint Prep Kit

Total Joint Prep Kit

Zinc Sulfate:

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Drug abuse and dependence
• Overdosage
• Dosage and administration
• How supplied
• Metro Plus (Zinc Sulfate) reviews

INDICATIONS AND USAGE

Metro Plus (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain Metro Plus (Zinc Sulfate) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of Metro Plus (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation.

Severe kidney disease may make it necessary to reduce or omit chromium and Metro Plus (Zinc Sulfate) doses because these elements are primarily eliminated in the urine.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

General

Do not use unless the solution is clear and the seal is intact.

Zinc 1 mg/mL should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of Metro Plus (Zinc Sulfate) from a bolus injection. Administration of Metro Plus (Zinc Sulfate) in the absence of copper may cause a decrease in serum copper levels.

Laboratory Tests

Periodic determinations of serum copper as well as Metro Plus (Zinc Sulfate) are suggested as a guideline for subsequent Metro Plus (Zinc Sulfate) administration.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of Metro Plus 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Metro Plus (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.

Pediatric Use

Pregnancy Category C. Animal reproduction studies have not been conducted with Metro Plus chloride. It is also not known whether Metro Plus (Zinc Sulfate) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Metro Plus (Zinc Sulfate) chloride should be given to a pregnant woman only if clearly needed.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

None known.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg Metro Plus (Zinc Sulfate) was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum Metro Plus (Zinc Sulfate) concentration of 207 mcg/dl. Symptoms abated within three hours.

Hyperamylasemia may be a sign of impending Metro Plus (Zinc Sulfate) overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).

Death resulted from an overdosage in which 1683 mg Metro Plus (Zinc Sulfate) was delivered intravenously over the course of 60 hours to a 72 year old patient.

Symptoms of Metro Plus (Zinc Sulfate) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum Metro Plus (Zinc Sulfate) level of 4184 mcg/dl.

Calcium supplements may confer a protective effect against Metro Plus (Zinc Sulfate) toxicity.

DOSAGE AND ADMINISTRATION

Metro Plus (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of Metro Plus (Zinc Sulfate) blood levels is suggested for patients receiving more than the usual maintenance dosage level of Metro Plus (Zinc Sulfate).

For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

HOW SUPPLIED

Metro Plus (Zinc Sulfate) 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).

Store at 20 to 25°C (68 to 77°F).

Revised: October, 2004

© Hospira 2004 EN-0488 Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

10 mL Vial

Metro Plus (Zinc Sulfate)

1 mg/mL

Metro Plus (Zinc Sulfate) Chloride Inj., USP

Rx only

FOR I.V. USE ONLY AFTER DILUTION.

HOSPIRA, INC., LAKE FOREST, IL 60045 USA