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CROMOLYN SODIUM



Amitsinh Vihol
Exam No-43
                     1
CROMOLYN SODIUM
According to WHO,
• Worldwide 235 millions patient of asthma
• In India, 15-20 million patient
 (15-20% are 5-11 year old children)
• 1,80,000 death every year in the world.

• First line agent into mild to moderate asthma
• Safer treatment, less adverse effect.




                                                  2
CROMOLYN SODIUM
PHARMACOLOGY
• Pharmacologic class: Chromone derivative
• Therapeutic class: Mast cell
  stabilizer, antiasthmatic, ophthalmic decongestant.
• Pregnancy risk category B
• Mechanism of Action-Inhibits release of histamine and
  reacting substances of anaphylaxis from mast cells, stabilizing
  the cell membrane and reducing the allergic response and
  inflammatory reaction.



                                                                    3
CROMOLYN SODIUM
Adverse reactions
• CNS: headache, dizziness
• Respiratory: wheezing, cough, nasal irritation, stuffy
  nose, sneezing, sore throat
• GI: nausea, diarrhea, stomachache
• Urinay: difficult or painful urination
• Skin: rash
• Other: altered taste, substernal burning, allergic
  reactions.



                                                           4
CROMOLYN SODIUM
INDICATION-
• Prophylactic in the management of patients with bronchial
  asthma.
• Prevention of exercise-induced bronchospasm;
• Adjunct in prevention of allergic disorders including rhinitis
CONTRAINDICATIONS-
• Contraindicated in those patients who have shown
  hypersensitivity to cromolyn sodium.



                                                                   5
CROMOLYN SODIUM
DOSAGE-
Usual Adult Dose for Asthma -- Maintenance:
• Nebulization solution: 20 mg 4 times a day at regular intervals.
• Metered dose inhaler: 2 puffs 4 times a day at regular
  intervals.
Usual Pediatric Dose for Asthma -- Maintenance:
• Nebulization solution:
  > 2 years: 20 mg 4 times a day at regular intervals.
• Metered dose inhaler:
  > 5 years: 2 puffs 4 times a day at regular intervals.

                                                                 6
CROMOLYN SODIUM
COMPETITOR-
• Fintal(Abbot)-(94RS/5 vial of each 2ml)

• Nalcrom (Sanofi-Aventis)-($10/20ml)

• Nasalcrom(Prestige Brands)-($9/13ml)




                                            7
CROMOLYN SODIUM
STORAGE & LABELLING-
•   Store at 20°-25°C (68°-77°F).
•   Do not use if solution is discolored or contains a precipitate.
•   Retain in foil pouch until time of use.
•   PROTECT FROM LIGHT.
•   KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF
    CHILDREN.




                                                                      8
CROMOLYN SODIUM
PACKAGING & AVAILABLE DOSAGE FORM-
• Packed in vial which is made from a low density polyethylene
  (LDPE) resin.
• Cromolyn Sodium Inhalation Solution Unit-Dose 2 mL Vial is
  supplied as a colorless to pale yellow solution containing 20
  mg cromolyn sodium, USP, in water for injection, USP, with 5
  vials per foil pouch in cartons as listed below.
• 60 vials per carton.
• 120 vials per carton.



                                                                  9
CROMOLYN SODIUM
PRICING
• 90Rs/5 vial Each contain 2ml

• 999Rs/Cartoon of 60 Vials

• 1999Rs/Cartoon of 120 vials




                                 10
11
CROMOLYN SODIUM
• REFRENCE-
• Rang & Dale’s Pharmacology by H.P.Rang, M.M.Dale, et all.,6th
  edition, Page no-364-365
• http://www.nlm.nih.gov/medlineplus/druginfo/meds/a60104
  2.html
• http://www.drugs.com/mtm/cromolyn-sodium-
  inhalation.html
• http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=AEC
  8F12A-B778-4AB5-A932-FDFB620FD50B#section-10



                                                              12
13

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Cromolyn sodium

  • 2. CROMOLYN SODIUM According to WHO, • Worldwide 235 millions patient of asthma • In India, 15-20 million patient (15-20% are 5-11 year old children) • 1,80,000 death every year in the world. • First line agent into mild to moderate asthma • Safer treatment, less adverse effect. 2
  • 3. CROMOLYN SODIUM PHARMACOLOGY • Pharmacologic class: Chromone derivative • Therapeutic class: Mast cell stabilizer, antiasthmatic, ophthalmic decongestant. • Pregnancy risk category B • Mechanism of Action-Inhibits release of histamine and reacting substances of anaphylaxis from mast cells, stabilizing the cell membrane and reducing the allergic response and inflammatory reaction. 3
  • 4. CROMOLYN SODIUM Adverse reactions • CNS: headache, dizziness • Respiratory: wheezing, cough, nasal irritation, stuffy nose, sneezing, sore throat • GI: nausea, diarrhea, stomachache • Urinay: difficult or painful urination • Skin: rash • Other: altered taste, substernal burning, allergic reactions. 4
  • 5. CROMOLYN SODIUM INDICATION- • Prophylactic in the management of patients with bronchial asthma. • Prevention of exercise-induced bronchospasm; • Adjunct in prevention of allergic disorders including rhinitis CONTRAINDICATIONS- • Contraindicated in those patients who have shown hypersensitivity to cromolyn sodium. 5
  • 6. CROMOLYN SODIUM DOSAGE- Usual Adult Dose for Asthma -- Maintenance: • Nebulization solution: 20 mg 4 times a day at regular intervals. • Metered dose inhaler: 2 puffs 4 times a day at regular intervals. Usual Pediatric Dose for Asthma -- Maintenance: • Nebulization solution: > 2 years: 20 mg 4 times a day at regular intervals. • Metered dose inhaler: > 5 years: 2 puffs 4 times a day at regular intervals. 6
  • 7. CROMOLYN SODIUM COMPETITOR- • Fintal(Abbot)-(94RS/5 vial of each 2ml) • Nalcrom (Sanofi-Aventis)-($10/20ml) • Nasalcrom(Prestige Brands)-($9/13ml) 7
  • 8. CROMOLYN SODIUM STORAGE & LABELLING- • Store at 20°-25°C (68°-77°F). • Do not use if solution is discolored or contains a precipitate. • Retain in foil pouch until time of use. • PROTECT FROM LIGHT. • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. 8
  • 9. CROMOLYN SODIUM PACKAGING & AVAILABLE DOSAGE FORM- • Packed in vial which is made from a low density polyethylene (LDPE) resin. • Cromolyn Sodium Inhalation Solution Unit-Dose 2 mL Vial is supplied as a colorless to pale yellow solution containing 20 mg cromolyn sodium, USP, in water for injection, USP, with 5 vials per foil pouch in cartons as listed below. • 60 vials per carton. • 120 vials per carton. 9
  • 10. CROMOLYN SODIUM PRICING • 90Rs/5 vial Each contain 2ml • 999Rs/Cartoon of 60 Vials • 1999Rs/Cartoon of 120 vials 10
  • 11. 11
  • 12. CROMOLYN SODIUM • REFRENCE- • Rang & Dale’s Pharmacology by H.P.Rang, M.M.Dale, et all.,6th edition, Page no-364-365 • http://www.nlm.nih.gov/medlineplus/druginfo/meds/a60104 2.html • http://www.drugs.com/mtm/cromolyn-sodium- inhalation.html • http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=AEC 8F12A-B778-4AB5-A932-FDFB620FD50B#section-10 12
  • 13. 13