Product Profile DISODIUM HYDROGEN CITRATE

 

Document Number:

Product Name:  DISODIUM HYDROGEN CITRATE

REASONS FOR REVIEW

Date	Reasons  for Review	Reference	Review Done on

 

NAME AND ADDRESS OF THE MANUFACTURING FACILITY:

Revision Number: NA

AUTHORIZATION

 

 

    Prepared By:  QA Chemist:               _____________________    ___________

                                                                                                Signature                                 Date

    Checked By:   QA Chemist:               _____________________    ___________

                                                                                                Signature                                 Date

    Approved By: QA Manager:               _____________________    ___________

                                                                                                Signature                                 Date

 

 

 

 

1.1. Product Name:
1.2. Generic Name:	Solution of Disodium Hydrogen Citrate
1.3. Label Claim:	Each 5 ml contains: Disodium Hydrogen Citrate B.P.  Colour:
1.4. Strength:
1.5. Product Description:
1.6. Packaging Types Available:
1.7. Mfg.Lic. No.
1.8. Batch sizes available:
1.9. Markets	India
1.10. Shelf Life
1.11. Indications	Disodium Hydrogen Citrate metabolizes and subsequently produces Sodium Bicarbonate in blood which in turn produces free Bicarbonate ions (HCO3-). These bicarbonate ions help restore the pH level of blood, bringing it back to7.42; the excess Bicarbonate ions pass through urine and alkalinizes it. Disodium hydrogen citrate is a urinary alkalinizer. It is used for the following condition:     Renal tubular acidosis (a condition where the blood is   acidic due to a kidney problem.     To prevent uric acid and cysteine stones in people predisposed to form the stones in the urinary tract.     To treat uterine tract infection, though evidence for the same has not been established.
1.12 Finished Product Specification No:
Active Pharmaceutical Ingredient   Specification no.
Standard Test Procedure No.
Master Formula Record No.
Annual Product Quality Review No.
Retrospective Validation  No.

 

                         2. BILL OF MATERIAL (Raw Material):-

·       BATCH SIZE            :  

 

Sl. No	Ingredients	Specification
01	Disodium Hydrogen Citrate	B.P.
02	Sodium Methyl Paraben	I.P.
03	Sodium Propyl Paraben	I.P.
04	Sodium Benzoate	I.P.
05	Colour Tartrazine	H.S.
06	Essence Lemon	H.S.
07	Sorbitol solution (70%)non crystalline	I.P.
08	Sodium Chloride	I.P.
09	Sodium Saccharin	I.P.
10	Purified water	I.P.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

                                           3. BILL OF MATERIAL (PACKING):-

 

Serial No.	Ingredients
	SALES PACK
1	Amber Coloured Pet Bottle 100 ml
2	Printed label
3	25 mm printed P.P. Cap
4	Box Label
5	Master Box (5 ply, 100 ml X 60 phials)
6.	BOPP Tape 2”
7.	Filter aid powder
8.	Filter Roll with circular filter paper
9.	Adhesive

 

 

 

 

 

 

 

 

 

 

 

 

 

4.    LIST OF SOP INVOLVED: -

Sl.No.	Name of SOP	SOP Number
01	SOP of APQR
02	SOP for Deviation
03	SOP for CAPA
04	SOP for Change Control Management
05	SOP for Product Recall
06	SOP for Market Complain
07	SOP for Training and Control
08	SOP for OOT
09	SOP for Incident Reporting and Management
10	SOP for Data Integrity
11	SOP for Good Documentation Practise
12	SOP for OOS
13	SOP for Operation and Cleaning of Storage vat
14	SOP for Operation and Cleaning of Sparkler Filter
15	SOP for Operation and Cleaning of Colloid Mill
16	SOP for Operation and Cleaning of Washing m/c
17	SOP for Operation and Cleaning of Bottle Filling m/c
18	SOP for Operation and Cleaning of Bottle Sealing m/c
19	SOP for Operation and Cleaning of Bottle Labelling  m/c
20	SOP for Operation and Cleaning of Inspection Hood
21	SOP for Master Formula Record
22	SOP for Life Period Of Product
23	SOP for Validation Master Plan With Hold-Time Studies
24	SOP for Annual Product Quality Review (APQR)

 

           5. Process Deviations / Change controls:              Nil

           6. Out of Specification and Out of trend:              Nil

           7. Non Conformance Report:                               Nil

           8. Product complaints:                                        Nil

           9. Returned goods or recalled products                Nil

           10. Adverse drug reactions:

This drug should not be used with the following medications because very serious interactions may occur: antacids that contain aluminum.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: aspirin and other salicylates (e.g., salsalate), lithium, quinidine.

If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise.

11. Active Pharmaceutical Ingredient data: Data Sheet from vendor attached

11. Raw material (API) Manufacturer / Supplier Performance review Name of API Manufacturer (Name and Address) :

Daffodil for India Posy Pharmachem Pvt.Ltd. 708 , Aakruti Building ,opp. Sardar Patel Stadium,Navrangpura ,Amehadabad-380009,Gujrat.

Phone no: 7926467765, 7926449966

            E. Mail IDProcurement:purchase@daffodilpharma.com, Marketing:marketing@daffodilpharma.com,Export :export@daffodilpharma.com,Import : exim@daffodilpharma.com,Customer Care : customercare@daffodilpharma.com

12. Material Safety Data Sheet: MSDS attached.

13. Received Consignments Approved Consignments Rejected Cause of Rejection: Nil

           14. Consumer Reviews – Alkasol Syrup  SOLUTION OF DISODIUM HYDROGEN  CITRATE

The following are the results of on-going survey on TabletWise.com for Alkasol Syrup. These results only indicate the perceptions of the website users. Please base your medical decisions only on the advice of a doctor or a registered medical professional.

Uses, Effectiveness and Side-effects

Following are the uses, perceived effectiveness and perceived side-effects incidence information reported by website visitor for Alkasol Syrup:

 

Uses

The most commonly reported use of this medicine is for 'Treatment of urinary tract infection'.

Use	Users	Percentile	Effective
Treatment of urinary tract infection	199
Treatment of burning micturition	166
Treatment of kidney stones	71
Infections of the urinary tract	43
Urinary tract infection	38
Alkalinisation of urine	32
Uric acid stones	16
Adjuvant treatment to sulphonamide therapy	8
Treating kidney stones	7
Treatment of uremic acidosis	7
Treatment of acidosis following diarrhea	7
Treatment of renal tubular acidosis	4

• Major
• Moderate
• Slight
• None
• Can't tell

Participants: 598

 

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Effective

130 out of 170 users report that this medicine is effective.

 

Effective	Users	Percentile
Works	130
Does not work	40

Participants:     170

 

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Onset of Action

'1 week' is the most commonly reported time for this medicine to be effective.

 

Duration	Users	Percentile
1 week	15
3 days	12
1 day	12
Same day	11
Within 2 hours	9
2 days	7

Participants: 80

 

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Incidents of Side-effects

30 out of 92 users report that this medicine has side-effects.

 

	Users	Percentile
No side-effect	62
Experienced side-effects	30

Participants: 92

 

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Reported Side-effects

'Stomach cramps' is the most commonly reported side-effect of this medicine.

Side-effect	Users	Percentile	Severity
Stomach cramps	6
Flatulence	4
Diuresis	3
Tiredness, mood swings	3
Anxiety	2
Overdosage or too rapid administration can cause metabolic alkalosis especially in renal impairment	2
Gastrointestinal ulceration	1
Diarrhea	1
Abdominal cramping	1

• Severe
• Moderate
• Mild

Participants: 23

 

 

 

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Long-term Side-effects

0 out of 8 users reported that they experienced long term side-effects while using this medicine for more than 3 months.

	Users	Percentile
Yes, experienced long-term side-effects	0
No, not experienced long-term side-effects	8

Participants: 8

 

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Side-effect Reported to Agency

No data has been collected for this survey

 

Allergic Reactions

0 out of 8 users have reported allergic reactions to this medicine.

 

	Users	Percentile
Yes, allergic to this medicine	0
No, not allergic to this medicine	8

Participants: 8

 

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Allergic Reaction Symptoms

No data has been collected for this survey

 

Consumption Behaviors

Following are the usage behaviors reported by website visitor for Alkasol Syrup:

 

Strengths

2 - 5 MG is the most commonly used strength of this medicine.

Strength	Users	Percentile
2 - 5 MG	16
5 - 10 MG	16
1 - 2 MG	13
0 - 1 MG	9
25 - 50 MG	9
10 - 25 MG	5
Other	16

Participants: 77

 

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Frequency of Use

Users report most commonly using this medicine 'thrice a day'.

	Users	Percentile
Thrice a day	33
Twice a day	33
Once a day	11
Once in 3 days	3
Once a week	1
Once in 2 days	1
Other	2

Participants:     82

 

 

 

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Timing

Users report most commonly using this medicine 'after food'.

Frequency	Users	Percentile
Empty Stomach	12
Before food	8
After food	50
Anytime	12

Participants: 82

 

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Regularity

16 out of 33 users report that they regularly use this medicine to manage their health.

	Users	Percentile
Yes, always, to control health problem	16
No, only when problem occurs or worsens	17

Participants: 33

 

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Time of Use

Users report most commonly using this medicine at 'morning, afternoon and night'.

Timing	Users	Percentile
Morning, afternoon and night	35
Morning and night	25
Morning only	6
Afternoon and night	4
Night only	4
Morning and afternoon	3
Afternoon only	3

Participants: 80

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Self-medication/Prescription

72 out of 88 users report that the medicine has been prescibed by a doctor.

 

	Users	Percentile
Prescribed by a doctor	72
Not prescribed by a doctor	16

Participants: 88

 

 

 

 

 

 

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Adherence

Users report always adhering to the prescribed schedule.

 

	Users	Percentile
Always	32
Often	16
Sometimes	21
Never	7

Participants: 76

 

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Reason for Non-adherence

"I experienced side effects" is the most commonly reported reason for non adherence of this medicine.

 

Reason	Users	Percentile
I experienced side effects	2
Financial reason	1

Participants: 3

 

Ease of Usage

Users most commonly report that it is not at all difficult to take this medicine as prescribed.

 

Difficulty	Users	Percentile
Not at all	6
A little	2
Somewhat	1

Participants: 9

 

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Habit Forming

0 out of 12 users report that this medicine is habit forming.

	Users	Percentile
Yes, is habit forming	0
No, not habit forming	12

Participants: 12

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Stopped Using

1 out of 8 users report that they have stopped using this medicine.

 

 

 

 

	Users	Percentile
Yes, stopped using	1
No, never stopped using	7

Participants: 8

 

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Reason to Stop Using

'Course of treatment ended' is the most commonly reported reason to stop using this medicine.

 

Reason	Users	Percentile
Course of treatment ended	1

Participants: 1

Cheaper Alternative

1 out of 9 users report that they have tried cheaper alternative to this medicine.

 

	Users	Percentile
Yes, tried cheaper alternative	1
No, not tried cheaper alternative	8

Participants: 9

 

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Cheaper Alternative Effectiveness

1 out of 1 users report that the cheaper alternatives to this medicine are effective.

	Users	Percentile
Yes, cheaper alternative is effective	1
No, cheaper alternative is not effective	0

Participants: 1

 

Price

Following are the perceptions about the price reported by the website visitors for Alkasol Syrup:

Price Perception

33 out of 92 users report that they find this medicine to be expensive.

	Users	Percentile
Expensive	33
Not Expensive	59

Participants: 92

 

 

 

 

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Demographics

Following is the demographic information reported by website visitors for Alkasol Syrup. Information below may include patient demographics as well as data for website visitors who might be researching on behalf of patients e.g. parents for small children. The data below may or may not be reflective of the complete patient population demographics for this medicine/health topic.

 

Gender

24 out of 37 users are male.

	Users	Percentile
Female	13
Male	24
Other	0

Participants: 37

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Age

The most common user is 21-30 years old.

 

	Users	Percentile
< 21	6
21-30	18
30-40	6
40-50	4
50+	5

Participants: 39

 

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Disease

Users most commonly suffer from Other.

	Users	Percentile
High blood pressure	3
Back pain	3
Depression	3
Diabetes	3
Chronic kidney disease	1
Asthma	1
Other	4

Participants: 18

 

 

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Body Weight

4 out of 36 users report that they are overweight.

	Users	Percentile
Overweight	4
Not overweight	32

Participants: 36

 

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Smoking Habit

34 out of 37 users report that they do not smoke.

	Users	Percentile
Smoke	3
Do not smoke	34

Participants: 37

 

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Alcohol Consumption Frequency

Users most commonly reported never using alcohol

 

	Users	Percentile
Never	31
One drink a day	0
Two drinks a day	0
More than two drinks a day	0
Once a week	0
Twice a week	0
Once a month	2

Participants: 33

 

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Well-being

17 out of 39 users report that they had significant pain in the last 3 months.

	Users	Percentile
Significant pain in the last 3 months	17
No significant pain in the last 3 months	22

Participants: 39

 

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Profession

Student is the most common profession reported by users.

 

 

 

 

	Users	Percentile
Student	8
House Maker	7
Family business	3
Doctor	3
Marketing	3
Government service	3
Other	7

Participants: 32

 

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Routine Health Check-ups

1 out of 1 users report that they receive routine health check-ups or physical examinations.

	Users	Percentile
Yes, receive routine health check-ups or physical examinations	1
No, do not receive routine health check-ups or physical examinations	0

Participants: 1

 

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Supplements

0 out of 1 users report that they take vitamins or herbal supplements.

	Users	Percentile
Yes, taking supplements	0
No, not taking supplements	1

Participants: 1

 

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Exercise Frequency

Users most commonly exercise once a week.

	Users	Percentile
Once a week	18
Twice a week	5
Five times a week	3
Everyday	11
Never	0

Participants: 37

 

 

 

 

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Fruits and Vegetables

Users most commonly report that they eat fruits and vegetables 'Everyday'.

	Users	Percentile
Everyday	1

Participants: 1

 

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Healthy Food Choices

Users most commonly report that they make a healthy food choice 'Always'.

	Users	Percentile
Always	1

Participants: 1

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Eating Out

No data has been collected for this survey

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Fast Food Frequency

No data has been collected for this survey

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Special Diet

0 out of 2 users report that they are on a special diet.

	Users	Percentile
Yes, on a special diet	0
No, not on a special diet	2

Participants: 2

 

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	Users	Percentile
Doctor's Clinic	2

Participants: 2

 

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Medicine Source

Users most commonly report to buy medicine from 'Local pharmacy'.

	Users	Percentile
Local pharmacy	1

Reference: www.tabletwise.com

15. Common Dosage:

 

Infants under 6 months: ¼ teaspoonfuls.

Up to 3 years: ½ teaspoonfuls.

Children up to 12 years:  ¾ teaspoonfuls.

Adults: 1 to 2 teaspoonfuls . 3 to 4 times daily.

The level of dosage varies on the age, physical condition, weight and medical history of the patient. Self medication is strictly discouraged as it can be very dangerous. Always seek the advice of a qualified doctor before taking this particular medicine.

• For adults, 15 ml per dose twice or thrice a day is recommended
• For children in the age range of 7-12 years, 5 ml per dose 2 or 3 times a day.
• The dosage for infants needs to be checked with a paediatrician.
• Missed dose: In case of a missed dose, it should be consumed as soon as one remembers. However, if time is coinciding with the next dose, then an individual should continue with the regular dose. One should not overdose to compensate the missed dose.
• Overdose: An individual should not take it  more than the prescribed dose. Doing so will not improve the conditions immediately and risk of undesired effect increases. If an individual overdoses on it by mistake, then a doctor should be consulted.

16. Warnings/Precautions-

• The medicine should be consumed after meals.
• A doctor or medical practitioner should be informed in advance regarding the ongoing medicines, herbal supplements, or health conditions.
• If an individual is suffering from severe kidney diseases or disorders such as high sodium level in blood or decreased urine output, then a doctor should be informed in advance.
• If an individual experiences troubled breathing, high blood pressure, low calcium levels, swollen ankles/feet/ legs due to water retention, irregular heartbeat and heart failure; a medical practitioner should be consulted as soon as possible.
• If an individual is pregnant or planning to get pregnant, then a medical practitioner should be informed at the time of prescribing liquid.
• The medicine should be avoided by people suffering from severe bacterial infections.
• Patients with history congestive heart failure should avoid the use of liquid.
• Dehydrated patients should avoid the use of liquid or proper electrolyte monitoring is recommended.
• Lactating mother should avoid the use of liquid.
• The liquid should not be consumed by patients with history of allergy to liquid or any of its ingredients.

17. Drug interactions:

Liquid when consumed along with other medicines might worsen the condition or neutralize the effect of either of the medicines. A list of medicines that should be avoided while consuming Liquid is mentioned below:

• Warfarin (Serious)
• Phenindione (Serious)
• Theophylline (Minor)
• Acenocoumarol (Nicoumalone) (Serious)
• Corticosteroids
• Barbiturates
• Ephedrine
• Amphetamines
• Methotrexate
• Salicylates
• Quinidine
• Tetracycline
• Pseudoephedrine
• Potassium depleting diuretics

18. Liquid Alcohol interactions:

It is advisable to not consume alcohol along with Liquid. Use of alcohol along with liquid might intensify the medical condition or result in some other undesired medical conditions.

19.  Diseases interactions:

Liquid Syrup when consumed in case of certain medical condition can either worsen the medical condition or produce some side effects. Hence, a doctor should be aware of medical history and present condition of the patient at the time of prescribing the medicine.

List of medical conditions when use of Liquid should be avoided is mentioned below:

• Kidney diseases: There is mild side effect on the organ. It is advised to monitor the functioning of the kidney while consuming the medicine, to avoid any severe condition. If an individual experiences any undesired effect, then a medical practitioner should be consulted without any delay. It is advisable to go for a suitable substitute or a dose adjustment.
• Liver diseases: Patient suffering from liver diseases should consume the medicine with caution. Functioning of liver should be monitored on regular basis to check the present condition of the person. If an individual experiences any side effects or if the condition worsens, then a medical practitioner should be consulted as soon as possible. In such case, dosage should be adjusted or A should be replaced with a suitable substitute.
• Heart disease: If an individual is suffering from heart disease or has a history of the same then one should inform the about the condition to a doctor at the time of prescribing the medicine. It is advisable to undergo regular check-up while consuming the medicine to avoid any severe effects. If an individual experienced any undesired condition, then a medical practitioner should be consulted. Also, if required  should be replaced with a suitable substitute or a proper dose adjustment should be done.
• Dehydration: If an individual is dehydrated, then use of should be avoided unless necessary or it should be consumed with plenty of water. If any undesirable effect is experienced, then a doctor should be consulted immediately.
• Edema: If an individual has complaint of Edema, then one should inform the condition to a medical practitioner at the time of prescribing the medicine. It is advisable to consult a doctor in case of any undesired effects.

20.  Lab interaction:

Liquid might interfere with some lab tests resulting false result. To avoid any such condition, a lab professional must be informed about the condition prior to the test.

21. Pregnancy Category

Category C : Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

22. Therapeutic Classification

Other Drugs Acting on the Genito-Urinary System

23. Available Medicines for DISODIUM HYDROGEN CITRATE in India: attached

24. Expert advice for DISODIUM HYDROGEN CITRATE: Expert advice attached

25. Other References:

1.     https://glowpink.com/blog/cital-syrup/

2.     https://toxnet.nlm.nih.gov/cgi-bin/sis/search/a?dbs+hsdb:@term+@DOCNO+375

3.     https://www.medindia.net/doctors/drug_information/disodium_hydrogen_citrate.htm

4.     https://docprime.com/disodiumydrogen-citrate-mddp

 

 https://www.researchgate.net/publication/346053784_Review_Article_of_Trial_of_combination_therapy_to_Treat_COVID-19_Infection?fbclid=IwAR2eC1c8c6gIOnrOHjPEo74F1nCyM0NyCZ8LJF-mfbp3wx966W5JrZzzRE0

 

 

 

Prepared By (sign/date):                                                         Checked By (sign/date):

 

            Approved By (sign/date):