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Diltiazem Hydrochloride Extended-Release Capsules, USP[Sun Pharma Global FZE] | Diltiazem Hydrochloride

04:40 EDT 27th August 2014 | BioPortfolio

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IMAGE chemical-str.jpg
MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND PLACEBO-CONTROLLED HYPERTENSION TRIALS
Placebo Diltiazem
Adverse Events
(COSTART Term)
n=57
# pts (%)
Up to 360 mg
n=149
# pts (%)
480 to 540 mg
n=48
# pts (%)
edema, peripheral
1 (2)
8 (5)
7 (15)
dizziness
4 (7)
6 (4)
2 (4)
vasodilation
1 (2)
5 (3)
1 (2)
dyspepsia
0 (0)
7 (5)
0 (0)
pharyngitis
2 (4)
3 (2)
3 (6)
rash
0 (0)
3 (2)
0 (0)
infection
2 (4)
2 (1)
3 (6)
diarrhea
0 (0)
2 (1)
1 (2)
palpitations
0 (0)
2 (1)
1 (2)
nervousness
0 (0)
3 (2)
0 (0)
MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND PLACEBO-CONTROLLED ANGINA TRIALSAdverse events occurring in treated patients at 2% or more than placebo-treated patients.
  Placebo Diltiazem
Adverse Events
(COSTART Term)
n=50
# pts (%)
Up to 360 mg
n=158
# pts (%)
540 mg
n=49
# pts (%)
headache
1 (2)
13 (8)
4 (8)
edema, peripheral
1 (2)
3 (2)
5 (10)
pain
1 (2)
10 (6)
3 (6)
dizziness
0 (0)
5 (3)
5 (10)
asthenia
0 (0)
1 (1)
2 (4)
dyspepsia
0 (0)
2 (1)
3 (6)
dyspnea
0 (0)
1 (1)
3 (6)
bronchitis
0 (0)
1 (1)
2 (4)
AV block
0 (0)
0 (0)
2 (4)
infection
0 (0)
2 (1)
1 (2)
flu syndrome
0 (0)
0 (0)
1 (2)
cough increase
0 (0)
2 (1)
1 (2)
extrasystoles
0 (0)
0 (0)
1 (2)
gout
0 (0)
2 (1)
1 (2)
myalgia
0 (0)
0 (0)
1 (2)
impotence
0 (0)
0 (0)
1 (2)
conjunctivitis
0 (0)
0 (0)
1 (2)
rash
0 (0)
2 (1)
1 (2)
abdominal enlargement
0 (0)
0 (0)
1 (2)
Strength
Description
Quantity
NDC#
120 mg
#2 purple colored cap and body with “669” imprinted in black ink on cap and body, containing white to off white pellets
 
30's CRC
47335-669-83
90's CRC
47335-669-81
90's NCRC
47335-669-19
500's NCRC
47335-669-13
1000's NCRC
47335-669-18
180 mg
#1 green colored cap and white colored body with “670” imprinted in black ink on cap and body, containing white to off white pellets
 
30's CRC
47335-670-83
90's CRC
47335-670-81
90's NCRC
47335-670-19
500's NCRC
47335-670-13
1000's NCRC
47335-670-18
240 mg
#0 purple colored cap and green colored body with “671” imprinted in black ink on cap and body, containing white to off white pellets
 
30's CRC
47335-671-83
90's CRC
47335-671-81
90's NCRC
47335-671-19
500's NCRC
47335-671-13
1000's NCRC
47335-671-18
300 mg
#00 purple colored cap and white colored body with “672” imprinted in black ink on cap and body, containing white to off white pellets
 
30's CRC
47335-672-83
90's CRC
47335-672-81
90's NCRC
47335-672-19
500's NCRC
47335-672-13
1000's NCRC
47335-672-18
360 mg
#00 green colored cap and body with “673” imprinted in black ink on cap and body, containing white to off white pellets
30's CRC
47335-673-83
90's CRC
47335-673-81
90's NCRC
47335-673-19
500's NCRC
47335-673-13
1000's NCRC
47335-673-18
IMAGE label-120mg.jpgIMAGE label-180mg.jpgIMAGE label-240mg.jpgIMAGE label-300mg.jpgIMAGE label-360mg.jpg

Manufacturer

Sun Pharma Global FZE

Active Ingredients

Source

Drugs and Medications [635 Associated Drugs and Medications listed on BioPortfolio]

Diltiazem hydrochloride [Sun Pharma Global FZE]

Diltiazem Hydrochloride Extended-Release Capsules, USP [Once-a-Day Dosage]

Diltiazem hydrochloride [Bryant Ranch Prepack]

Diltiazem hydrochloride

Diltiazem hydrochloride [Forest Laboratories, Inc.]

Diltiazem hydrochloride Extended Release Capsules

Diltiazem hydrochloride [Med-Health Pharma LLC.]

Diltiazem hydrochloride Extended Release Capsules

Diltiazem hydrochloride [Physicians Total Care, Inc.]

Diltiazem hydrochloride Extended Release Capsules

Clinical Trials [2021 Associated Clinical Trials listed on BioPortfolio]

Low Dose of Diltiazem for Rate Control of Atrial Fibrillation

This study is to show the efficacy and safety of low dose diltiazem for the treatment of atrial fibrillation with rapid ventricular response in emergency room. We will compare the standard...

Pharmacokinetic Interaction Between Diltiazem and ACT-541468 in Healthy Subjects

The main objective of this study is to investigate whether repeated administration of a cardiac medication (diltiazem) can affect the pharmacokinetics (i.e., amount and time of presence in...

Oral vs Intravenous Diltiazem for Rapid Atrial Fibrillation/Flutter Trial

The primary objective of this study is to compare the incidence of rate control (defined as: HR

A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Pharmacokinetics of BMS-986177 in Healthy Subjects

The study is being conducted to assess the effects of co-administration of itraconazole or diltiazem, respectively, on the pharmacokinetic (PK) parameters Cmax, AUC(INF), and AUC(0-T) of B...

Diltiazem vs. Metoprolol in the Acute Management of AF in Patients With HFrEF

Atrial fibrillation (AF) is the most common arrhythmia, accounting for one third of all hospital admissions and 1% of all emergency department visits (ED). Approximately 65% of those prese...

PubMed Articles [209 Associated PubMed Articles listed on BioPortfolio]

Two Fatal Cases Involving Cardiovascular Drugs Diltiazem and Amlodipine.

A liquid chromatographic tandem mass spectrometric method for the identification and quantification of 18 cardiovascular drugs was developed in order to evaluate two cases of fatal intoxication involv...

Evidence for the involvement of TNF-α, IL-1β and IL-10 in the antinociceptive and anti-inflammatory effects of indole-3-guanylhydrazone hydrochloride, an aromatic aminoguanidine, in rodents.

Indole-3-guanylhydrazone hydrochloride (LQM01) is a new derivative of aminoguanidine hydrochloride, an aromatic aminoguanidine.

Topical Minoxidil Versus Topical Diltiazem for Chemical Sphincterotomy of Chronic Anal Fissure: A Prospective, Randomized, Double-Blind, Clinical Trial.

Anal fissure is a common anorectal problem causing severe pain and discomfort to the patients. Chemical sphincterotomy has emerged as a noninvasive alternative to the surgical methods of fissure treat...

Association between total dose of ritodrine hydrochloride and pulmonary oedema in twin pregnancy: a retrospective cohort study in Japan.

Pulmonary oedema is recognised as a severe side effect of ritodrine hydrochloride. Recently, the number of twin pregnancies has been increasing. Few studies have reported the association between total...

In vitro screening of selected antiviral drugs against betanodavirus.

The inhibitory effects of ammonium chloride (NHCl) and chlorpromazine hydrochloride on betanodavirus were evaluated on Sahul Indian sea bass kidney (SISK) cell line. The cytotoxicity of different conc...

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