Doxycycline for Injection USP 200mg (Doxitaj)
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Doxycycline for Injection USP 200mg Technical Specification:

Product Name:Doxycycline for Injection USP 200mg
Brand Name:Doxitaj
Strength:100mg, 200mg
Dosage Form:Lyophilized
Dry Powder Injection (Sterile) *Preservative Free
Packing:1 Vial + 1 Ampule + WFI Tray
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Broad-Spectrum Antibiotic (tetracycline) & Anti-bacterial
Indication: Doxycycline is in a class of medications called tetracycline antibiotics. It works to treat infections by preventing the growth and spread of bacteria.
Storage:Store in cool, dry & dark place. Store at 20°C to 25°C.  Protect from light.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Doxycycline for Injection USP 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  •  Doxycycline for Injection USP 200mg
    a)     Each Vial Contains:
    Doxycycline Hyclate (Sterile) USP
    Equivalent to Doxycycline ….…….200 mg
    b) Ascorbic Acid Injection USP
    Each 5ml contains:
    Ascorbic Acid USP……………….500mg
    Water for Injection USP…………. q.s
    c) Sterile Water for Injection USP……10ml

THERAPEUTIC INDICATIONS:

Doxycycline is in a class of medications called tetracycline antibiotics. It works to treat infections by preventing the growth and spread of bacteria. It works to treat acne by killing the bacteria that infects pores and decreasing a certain natural oily substance that causes acne

DIRECTION OF USE:

MUST BE FURTHER DILUTED AFTER RECONSTITUTION

Reconstituted solutions must be stored and used as prescribed. They must be used within the time period as described. Protect solution from direct sunlight during infusion.

  • Each 100mg of Doxycycline (i.e. withdraw entire solution from the 100 mg vial) is further diluted with 100 to 1000 mL of the intravenous solutions listed below:
  1. 9% Sodium Chloride Injection USP
  2. 5% Dextrose Injection BP

This will result in desired concentrations of 0.1 to 1 mg/mL concentrations lower than 0.1 mg/mL or higher than 1mg/mL are not recommended.

CAUTION & Warning:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.

Reconstituted solution should be used immediately after preparation.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

Retain in carton until time of use.
Reconstituted solutions must be stored and used as prescribed.

They must be used within the time period as described.
Protect solution from direct sunlight during infusion.

Warning: To be sold by retail on the prescribed of a registered medical partitioner only.

STORAGE & DOSAGE:

Storage: Store in cool, dry & dark place. Store at 20°C to 25°C.  Protect from light.

Vial stopper do not contain natural rubber latex.

Keep all medicines out of reach of children.

Dosage: As directed by Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Doxycycline for Injection USP 100mg
B. Doxycycline for Injection USP 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Doxycycline for Injection USP 100mg
a) Each Vial Contains:
Doxycycline Hyclate (Sterile) USP
Equivalent to Doxycycline ….…….100 mg
b) Ascorbic Acid Injection USP
Each 5ml contains:
Ascorbic Acid USP……………….500mg
Water for Injection USP…………. q.s
c) Sterile Water for Injection USP……10ml

2) Doxycycline Hydrochloride USP 200mg
a) Each Vial Contains:
Doxycycline Hyclate (Sterile) USP
Equivalent to Doxycycline ….…….200 mg
b) Ascorbic Acid Injection USP
Each 5ml contains:
Ascorbic acid USP……………….500mg
Water for Injection USP…………. q.s
c) Sterile Water for Injection USP……10ml

THERAPEUTIC INDICATIONS:

Doxycycline is in a class of medications called tetracycline antibiotics. It works to treat infections by preventing the growth and spread of bacteria. It works to treat acne by killing the bacteria that infects pores and decreasing a certain natural oily substance that causes acne

DIRECTION OF USE:

MUST BE FURTHER DILUTED AFTER RECONSTITUTION
Reconstituted solutions must be stored and used as prescribed.
They must be used within the time period as described.
Protect solution from direct sunlight during infusion.
1. Each 100mg of Doxycycline (i.e. withdraw entire solution from the 100 mg vial) is further diluted with 100 to 1000 mL of the intravenous solutions listed below:
A. 0.9% Sodium Chloride Injection USP
B. 5% Dextrose Injection BP
This will result in desired concentrations of 0.1 to 1 mg/mL concentrations lower than 0.1 mg/mL or higher than 1mg/mL are not recommended.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution.
Reconstituted solution should be used immediately after preparation.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Retain in carton until time of use.
Reconstituted solutions must be stored and used as prescribed.
They must be used within the time period as described.
Protect solution from direct sunlight during infusion.
WARNING: To be sold by retail on the prescribed of a registered medical partitioner only.

STORAGE & DOSAGE:

Storage: Store in cool, dry & dark place. Store at 20°C to 25°C. Protect from light.
Vial stopper do not contain natural rubber latex.
Keep all medicines out of reach of children.
Dosage: As directed by Physician.