INTRODUCTION

AQUADOL SPAS INJECTION contains a combination of Diclofenac and Dicyclomine, which belongs to the group of medicines called Non-steroidal Anti-inflammatory drugs (NSAIDs) and Antispasmodics. AQUADOL SPAS INJECTION is used to relieve pain, swelling and muscle spasms in the stomach or intestine (such as irritable bowel syndrome etc.), abdominal pain and menstrual cramps (throbbing or cramping pains in the lower apart of the stomach).

Irritable bowel syndrome is a condition causing recurrent stomach pain, spasms of muscles involving the intestine, diarrhea or constipation etc.

Your doctor might want you to take certain diagnostic tests before or while receiving AQUADOL SPAS INJECTION such as liver function test or kidney function test to monitor your liver and kidney functions.

AQUADOL SPAS INJECTION is not recommended for use in patients with heart, liver or kidney diseases, increased eye pressure (glaucoma), myasthenia gravis, ulcerative colitis, reflux esophagitis, bleeding in the digestive system, intestinal obstruction, urinary obstruction or stomach or intestinal ulcers.

Before receiving AQUADOL SPAS INJECTION, inform your doctor if you have lung diseases, porphyria, lupus, dehydration, diabetes, high blood pressure or raised cholesterol level.

AQUADOL SPAS INJECTION should be used in pregnant women only if clearly needed and is not recommended for use during last 3 months of pregnancy. AQUADOL SPAS INJECTION is not advised to be used in breast feeding women.

The most common side effects of receiving AQUADOL SPAS INJECTION are dizziness, dry mouth, vision blurred, nausea, headache, dizziness, vertigo or pain at injection site. Contact your doctor if the any of these symptoms worsen or doesn’t improve.

USES OF AQUADOL SPAS INJECTION

Treats:

• IBS- irritable bowel syndrome (a condition with recurrent stomach pain, spasm of muscles in the intestine, diarrhea or constipation)
• stomach pain
• muscle cramps

HOW AQUADOL SPAS INJECTION WORKS

AQUADOL SPAS INJECTION is a combination of Diclofenac and Dicyclomine. Diclofenac is a Non-steroidal anti-inflammatory drug that works by inhibiting the release cyclooxygenase, a chemical messenger that produces fever, discomfort and inflammation in the body (redness and swelling). Dicyclomine is an Anticholinergic that decreases and relaxes the abnormal muscle contractions in the stomach and intestine by acting on certain receptors called acetylcholine receptors and directly on smooth muscles.

DIRECTIONS FOR USE

AQUADOL SPAS INJECTION will be given to you only by a doctor or a nurse into a muscle as an intramuscular injection (I.M). Your doctor will decide the dose and frequency of AQUADOL SPAS INJECTION depending on the severity of your existing condition and another comorbidity.

SIDE EFFECTS OF AQUADOL SPAS INJECTION

HOW TO MANAGE SIDE EFFECTS

Diarrhea:

Drink lots of fluids, such as water or fruit juice to keep yourself hydrated. Do not consume any medicine on your own without consulting your doctor. Ask for your doctor’s advice if diarrhea doesn’t improve.

Nausea:

Stick to simple meals while receiving AQUADOL SPAS INJECTION. Avoid eating rich or spicy food. Do not take any medication on your own. Ask for your doctor’s advice if nausea doesn’t improve.

Headache:

Try to take rest and don’t involve yourself in exertive activities. Rest in a quiet and dark room. Apply a pain-relieving balm on your forehead. Ask for your doctor’s advice if headache doesn’t improve

Vomiting:

Drink clear or ice-cold drinks. Eat light, bland foods and avoid fried, oily or sweet foods. Avoid carbonated drinks. Ask for your doctor’s advice if vomiting doesn’t improve.

Dizziness:

Lie or sit down immediately when you feel dizzy. If you're feeling severe episode of spinning(vertigo), lie in a dark and quite place with eyes closed. Try to avoid vehicle driving. Discuss with your doctor if the symptom worsens.

Dry mouth:

Dry mouth can be managed by chewing sugar-free gum or sucking on sugar-free hard candies to stimulate the flow of saliva. Sip water at regular intervals of time. Do not use mouthwashes that contain alcohol because they can be drying. Consult your physician for advice.

WARNING & PRECAUTIONS

PREGNANCY

AQUADOL SPAS INJECTION should only be used in pregnant women only if clearly needed and should not be used during the last three months of pregnancy as it could harm your unborn child or cause problems during delivery. Consult your doctor for advice before receiving AQUADOL SPAS INJECTION.

BREASTFEEDING

AQUADOL SPAS INJECTION is not recommended for use in breastfeeding mothers as small amounts of it passes into breast milk. Consult your doctor for advice.

DRIVING AND USING MACHINES

Do not drive or operate any machines if you feel dizzy, tired, sleepy or have blurred vision after receiving AQUADOL SPAS INJECTION.

ALCOHOL

Avoid consumption of alcohol while taking AQUADOL SPAS INJECTION as it increases the chance of bleeding from the digestive system.

KIDNEY

AQUADOL SPAS INJECTION is not recommended for use in patients with kidney disease such as obstructive uropathy (inability to urinate, blood in the urine etc.), volume depletion etc. Consult your doctor before receiving AQUADOL SPAS INJECTION.

LIVER

AQUADOL SPAS INJECTION is not recommended for use in with liver diseases. Consult your doctor for advice.

ALLERGY

Do not receive AQUADOL SPAS INJECTION if you are allergic to Diclofenac, Dicyclomine, Aspirin and other NSAIDs or any other ingredients of this medicine.

LUNGS

AQUADOL SPAS INJECTION should be used with caution in patients with lung diseases such as asthma, hay fever, chronic obstructive pulmonary disease (COPD). Consult your doctor for advice.

HEART DISEASE

AQUADOL SPAS INJECTION is not recommended for use in patients with heart disease such as severe heart failure, block in blood vessels of the heart, heart attack etc. AQUADOL SPAS INJECTION should be used with caution in patients with other heart diseases. Also, inform your doctor if you have recently undergone any surgical procedure for your heart (CABG/ bypass heart surgery, PTCA, RF ablation, pacemaker etc.). Consult with your doctor before receiving AQUADOL SPAS INJECTION.

INTERACTIONS

A. Drug-Drug interactions:

Before receiving AQUADOL SPAS INJECTION inform your doctor if you are taking any of the following medicines:

• lithium or selective serotonin-reuptake inhibitors (SSRI’s), (medicines used to treat some types of depression)
• diuretics such as spironolactone, furosemide (medicines used to increase the amount of urine)
• enalapril, ramipril, propranolol, bisoprolol, digoxin (used to treat high blood pressure or heart failure)
• aspirin or ibuprofen (used to relieve pain)
• mifepristone (a medicine used to terminate pregnancy)
• prednisolone (medicines used to provide relief for inflamed areas of the body)
• warfarin (medicines used to prevent blood-clotting)
• sitagliptin, metformin (used to treat diabetes, except insulin)
• methotrexate (used to treat some kinds of cancer or arthritis)
• ciclosporin, tacrolimus (used in patients who have received organ transplants)
• trimethoprim (used to prevent or treat urinary tract infections)
• levofloxacin, ciprofloxacin (used to treat bacterial infections)
• voriconazole (used to treat serious fungal infections)
• phenytoin (medicine to treat epilepsy)
• colestipol, cholestyramine (used to lower cholesterol)
• loratadine, cetirizine (used to treat allergies)
• metoclopramide (used to treat vomiting)
• aluminum hydroxide, magnesium carbonate (used to treat acidity)

Overdosage:

AQUADOL SPAS INJECTION will be administered to you only by a doctor or a nurse in a hospital and so it is unlikely to receive an overdose. However, consult your doctor or nurse if you experience any unusual symptoms while receiving AQUADOL SPAS INJECTION such as lethargy, drowsiness/dizziness, nervousness, dryness of mouth, difficulty in swallowing, nausea, vomiting, blurring of vision, stomach pain, muscle weakness, black or tarry stool due to bleeding in the digestive system, etc. Contact your doctor immediately if the symptoms are worsening or persists.

SYNOPSIS

MORE INFORMATION

• Keep AQUADOL SPAS INJECTION out of reach from children
• Store AQUADOL SPAS INJECTION at room temperature below 25°C

FAQs ABOUT AQUADOL SPAS INJECTION

Can AQUADOL SPAS INJECTION be used for stomach pain?

AQUADOL SPAS INJECTION can be used to relieve pain and muscle cramps in the stomach, only if recommended by your doctor after outweighing the risks and benefits. Consult with your doctor before receiving.

Can AQUADOL SPAS INJECTION cause diarrhea?

Diarrhea is a common side effect of receiving AQUADOL SPAS INJECTION. Drink lots of fluids, such as water or fruit juice to keep yourself hydrated. Do not consume any medicine on your own without consulting your doctor. Ask for your doctor’s advice if diarrhea doesn’t improve.

Can AQUADOL SPAS INJECTION be used during pregnancy?

AQUADOL SPAS INJECTION should only be used in pregnant women only if clearly needed and should not be used during the last three months of pregnancy as it could harm your unborn child or cause problems during delivery. Consult your doctor for advice before receiving AQUADOL SPAS INJECTION.

Is AQUADOL SPAS INJECTION safe for use in a patient with kidney disease?

AQUADOL SPAS INJECTION is not advised for use in patients with severe kidney diseases such as kidney failure, obstructive uropathy, renal insufficiency etc. Your doctor will evaluate your existing condition before recommending you AQUADOL SPAS INJECTION.

Do I need to undergo any tests before or while receiving AQUADOL SPAS INJECTION?

Your doctor might want you to take certain diagnostic tests before or while receiving AQUADOL SPAS INJECTION such as liver function test or kidney function test to monitor your liver and kidney functions.

REFERENCES

1. KD. Tripathi. NSAIDs and antipyretic-analgesics & anticholinergic drugs and drugs acting on autonomic ganglia. Essentials of medical pharmacology. 8th Edition. 2019. Page – 221 & 129.

2. Laurence Brunton, Bruce Chabner, Bjorn Knollman. Muscarinic receptor antagonist and agonist. Goodman & Gilman’s The Pharmacological Basis of Therapeutics. 12th Edition. 2006. Page- 233.

3. Tong J Gan. Diclofenac: an update on its mechanism of action and safety profile. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. July 2010. [Accessed on 1st December 2022]. https://pubmed.ncbi.nlm.nih.gov/20470236/

4. NIH National Library of Medicine, National center for biotechnology information. Dicyclomine. Pubchem. [Accessed on 1st December 2022]. https://pubchem.ncbi.nlm.nih.gov/compound/Dicyclomine

5. Magdalena Janczura, Malgorzata Kobus-Moryson, Szymon Sip, Marcin Zarowski, Agnieszka Warenczak, Judyta Cielecka-Piontek. Multidisciplinary Digital Publishing Institute journals (MDPI). Fixed-Dose Combination of NSAIDs and Spasmolytic Agents in the Treatment of Different Types of Pain. [Revised on 18th June 2021] [Accessed on 1st December 2022]. https://www.mdpi.com/2077-0383/10/14/3118/htm

6. LEK Pharmaceuticals. Health Products Regulatory Authority (HPRA). [Revised in December 2019]. [Accessed on 1st December 2022]. http://www.hpra.ie/img/uploaded/swedocuments/e1ace799-5f7d-4c93-a5cd-2edd2724fc0d.pdf

7. Akorn. Dicyclomine Hydrochloride Injection. Dailymed. [Revised in July 2022]. [Accessed on 1st December 2022]. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e1592ba-03cd-4831-bd7c-4c0eeaa06fd1

8. Integrated Laboratories. Intospas (Diclofenac + Dicyclomine). [Accessed on 1st December 2022]. https://integratedlaboratories.in/diclofenac-dicyclomine-injection-intopas/

9. Themis Medicare. Aquadol Spas Injection (Diclofenac + Dicyclomine). [Accessed on 1st December 2022]. https://www.themismedicare.com/products/therapeutic-products

USEFUL DIAGNOSTIC TESTS

• Complete Blood Count
• Liver Function Test
• Kidney Function Test

AUTHOR DETAILS

Written By Dr. Priyanka Goel, BDS
Last updated on 02 Dec 2022 | 06:04 PM(IST)